Phase 4
Completed N=98
A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
Antiplatelet Aggregation
Source: ClinicalTrials.gov NCT00493779 ↗
Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Aug 2009
Primary outcomePrimary: Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) — 223.76; 35.04; 38.88; 32.74 percent change
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) |
223.76; 35.04; 38.88; 32.74; 39.42 | — |
| SECONDARY Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin |
44.59; 9.00; 11.10; 3.63; 1.90 | — |
| SECONDARY Adjusted Mean Percent Changes From Baseline in Hs-CRP |
1.70; -20.59; -22.89; -19.32; -17.70 | — |
| SECONDARY Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up |
0; 20; 0; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00493779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.