A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients (DECADES)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00493779
First received: June 27, 2007
Last updated: August 3, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Antiplatelet Aggregation
Procedure: Blood Collection
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) [ Time Frame: Week 1, Week 2, Week 3, Week 4 (primary timepoint) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin [ Time Frame: Week 1, Week 2, Week 3, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Percent Changes From Baseline in Hs-CRP [ Time Frame: Week 1, Week 2, Week 3, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up [ Time Frame: Throughout 4-week follow-up period ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 103
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws
Procedure: Blood Collection
4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493779

Locations
France
Local Institution
Paris, France, 75013
Germany
Local Institution
Mainz, Germany, 55101
Netherlands
Local Institution
Nieuwegein, Netherlands, 3435 CM
Local Institution
Rotterdam, Netherlands, 3015 GD
United Kingdom
Local Institution
Glasgow, Central, United Kingdom, G11 6NT
Local Institution
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00493779     History of Changes
Other Study ID Numbers: CV149-208, Eudract number: 2007-000713-11
Study First Received: June 27, 2007
Results First Received: June 5, 2009
Last Updated: August 3, 2010
Health Authority: France: Agence du Medicament (Drug Agency)

Additional relevant MeSH terms:
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014