Antiplatelet Aggregation Clinical Trial
— DECADESOfficial 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)
| Verified date | June 2010 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Agence du Medicament (Drug Agency) |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | June 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Local Institution | Paris | |
| Germany | Local Institution | Mainz | |
| Netherlands | Local Institution | Nieuwegein | |
| Netherlands | Local Institution | Rotterdam | |
| United Kingdom | Local Institution | Glasgow | Central |
| United Kingdom | Local Institution | Southampton | Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Sanofi |
France, Germany, Netherlands, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) | 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. | Week 1, Week 2, Week 3, Week 4 (primary timepoint) | No |
| Secondary | Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin | 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. | Week 1, Week 2, Week 3, Week 4 | No |
| Secondary | Adjusted Mean Percent Changes From Baseline in Hs-CRP | 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 รท 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. | Week 1, Week 2, Week 3, Week 4 | No |
| Secondary | Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up | 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. | Throughout 4-week follow-up period | Yes |