## Protocol Section
### Identification Module
**NCT ID:** NCT00493779

**Acronym:** DECADES

**Brief Title:** A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients

**Official Title:** An Exploratory, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)

#### Organization Study ID Info
**ID:** CV149-208
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
#### Secondary ID Infos
**ID:** Eudract number: 2007-000713-11
### Status Module
#### Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-08-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-08-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2009-08-11

**Type:** ESTIMATED

**Results First Submit Date:** 2009-06-05

**Results First Submit QC Date:** 2009-08-10

#### Start Date
**Date:** 2007-10

**Status Verified Date:** 2010-06

#### Study First Post Date
**Date:** 2007-06-28
**Type:** ESTIMATED
**Study First Submit Date:** 2007-06-27
**Study First Submit QC Date:** 2007-06-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Sanofi

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Old Name Title:** Study Director

**Old Organization:** Bristol-Myers Squibb

### Description Module

**Brief Summary:** The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel

### Conditions Module

**Conditions:**

- Antiplatelet Aggregation

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 103

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws

**Intervention Names:**

- Procedure: Blood Collection

**Label:** 1

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 4 weeks

**Name:** Blood Collection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.

**Measure:** Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)

**Time Frame:** Week 1, Week 2, Week 3, Week 4 (primary timepoint)

#### Secondary Outcomes

**Description:** Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.

**Measure:** Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin

**Time Frame:** Week 1, Week 2, Week 3, Week 4

**Description:** ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.

**Measure:** Adjusted Mean Percent Changes From Baseline in Hs-CRP

**Time Frame:** Week 1, Week 2, Week 3, Week 4

**Description:** An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

**Measure:** Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up

**Time Frame:** Throughout 4-week follow-up period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
* Subjects receiving low dose ASA
* Subjects receiving a statin
* Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
* Subjects with no clinical history of diabetes mellitis
* Men and women, ages 18 years or older

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Paris

**Country:** France

**Facility:** Local Institution

**Zip:** 75013

**Location 2:**

**City:** Mainz

**Country:** Germany

**Facility:** Local Institution

**Zip:** 55101

**Location 3:**

**City:** Nieuwegein

**Country:** Netherlands

**Facility:** Local Institution

**Zip:** 3435 CM

**Location 4:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Local Institution

**Zip:** 3015 GD

**Location 5:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** Local Institution

**State:** Central

**Zip:** G11 6NT

**Location 6:**

**City:** Southampton

**Country:** United Kingdom

**Facility:** Local Institution

**State:** Hampshire

**Zip:** SO16 6YD

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Wykrzykowska JJ, Warnholtz A, de Jaeger P, Curzen N, Oldroyd KG, Collet JP, Ten Berg JM, Rademaker T, Goedhart D, Lissens J, Kint PP, Serruys PW. Effect of clopidogrel discontinuation at 1 year after drug eluting stent placement on soluble CD40L, P-selectin and C-reactive protein levels: DECADES (Discontinuation Effect of Clopidogrel After Drug Eluting Stent): a multicenter, open-label study. J Thromb Thrombolysis. 2009 Nov;28(4):410-7. doi: 10.1007/s11239-009-0354-y.

**PMID:** 19504052

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M1669

- Name: Clopidogrel

- Relevance: LOW

- As Found: Unknown

- ID: M4548

- Name: Aspirin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Clopidogrel Withdrawal Population

**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.

**ID:** EG000

**Other Num at Risk:** 98

**Serious Number Affected:** 2

**Serious Number At Risk:** 98

**Title:** Clopidogrel Withdrawal Population

**Frequency Threshold:** 5

#### Serious Events

**Term:** Non-cardiac chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 98

**Term:** Angina unstable

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 98

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 98

**Units:** Participants

### Group

**ID:** BG000

**Title:** Clopidogrel Withdrawal Population

**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.5

**Value:** 63.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 44

**Upper Limit:** 81

**Value:** 63

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 78

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 93

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 5

**Class Title:** Asian Oriental

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.052

**Value:** 1.70

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.898

**Value:** 44.59

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 186.513

**Value:** 223.76

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline High Sensitivity C-Reactive Protein (hs-CRP)
**Unit of Measure:** mg/L
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline Plasma Soluble P-Selectin
**Unit of Measure:** ng/mL
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline Soluble CD40 Ligand
**Unit of Measure:** ng/L
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The open-label and exploratory nature of this small study and the absence of control group inherently limit the interpretability of the results.
### Point of Contact
**Email:** Clinical.Trials@bms.com
**Organization:** Bristol-Myers Squibb
**Title:** BMS Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.53
- **Upper Limit:** 
- **Value:** 44.59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.38
- **Upper Limit:** 
- **Value:** 9.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.11
- **Upper Limit:** 
- **Value:** 11.10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.69
- **Upper Limit:** 
- **Value:** 3.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.76
- **Upper Limit:** 
- **Value:** 1.90
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.14
- **Upper Limit:** 
- **Value:** 223.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.37
- **Upper Limit:** 
- **Value:** 35.04
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.76
- **Upper Limit:** 
- **Value:** 38.88
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.68
- **Upper Limit:** 
- **Value:** 32.74
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.07
- **Upper Limit:** 
- **Value:** 39.42
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** 1.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.76
- **Upper Limit:** 
- **Value:** -20.59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.78
- **Upper Limit:** 
- **Value:** -22.89
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.22
- **Upper Limit:** 
- **Value:** -19.32
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.48
- **Upper Limit:** 
- **Value:** -17.70
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Title:** Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 2
**Description:** Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4 (primary timepoint)
**Title:** Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
**Type:** PRIMARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 3
**Description:** ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Title:** Adjusted Mean Percent Changes From Baseline in Hs-CRP
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 4
**Description:** An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
**Parameter Type:** NUMBER
**Population Description:** All enrolled patients in whom clopidogrel treatment was discontinued.
**Reporting Status:** POSTED
**Time Frame:** Throughout 4-week follow-up period
**Title:** Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
**ID:** OG000
**Title:** Clopidogrel Withdrawal Population
### Participant Flow Module
#### Group
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
**ID:** FG000
**Title:** Clopidogrel Withdrawal Population
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Logistical issue at site
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 98
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 97
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Pre-Assignment Details:** 103 subjects who were enrolled and treated with clopidogrel, were enrolled, of which 98 subjects had discontinued clopidogrel treatment and entered follow-up phase (study phase).
**Has Results:** True