NCT00493779

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 11, 2009

Completed
Last Updated

August 10, 2010

Status Verified

June 1, 2010

Enrollment Period

8 months

First QC Date

June 27, 2007

Results QC Date

June 5, 2009

Last Update Submit

August 3, 2010

Conditions

Antiplatelet Aggregation

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin

    Week 1, Week 2, Week 3, Week 4

  • Adjusted Mean Percent Changes From Baseline in Hs-CRP

    Week 1, Week 2, Week 3, Week 4

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

    Throughout 4-week follow-up period

Study Arms (1)

1

NO INTERVENTION

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

Procedure: Blood Collection

Interventions

Blood CollectionPROCEDURE

4 weeks

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution

Paris, 75013, France

Location

Local Institution

Mainz, 55101, Germany

Location

Local Institution

Nieuwegein, 3435 CM, Netherlands

Location

Local Institution

Rotterdam, 3015 GD, Netherlands

Location

Local Institution

Glasgow, Central, G11 6NT, United Kingdom

Location

Local Institution

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • 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: 19504052BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

The open-label and exploratory nature of this small study and the absence of control group inherently limit the interpretability of the results.

Results Point of Contact

Title
BMS Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 10, 2010

Results First Posted

August 11, 2009

Record last verified: 2010-06

Locations

NL(2)DE(1)FR(1)GB(2)