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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Antiplatelet Aggregation

Intervention / Treatment
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* Procedure: Blood Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws | Procedure: Blood Collection<br>* 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 ÷ 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 | 
| 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 |