NCT00343876

Clopidogrel and Aspirin Together: The Effect on C-Reactive Protein Trial

A Single Center, Double-Blind, Randomized Trial to Evaluate the Effects of Aspirin 325 mg + Clopidogrel 75 mg v. Aspirin 325 mg + Placebo on Plasma Concentration of C-Reactive Protein: The CATER Trial Protocol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Inflammation is associated with worsening outcomes among individuals with CAD; C-reactive protein is a well-known marker of inflammation. Both healthy patients and those with a history of CAD who exhibit elevated CRP are at greater risk for cardiovascular events. Despite CRP's well- documented association with increased risk in the development and progression of CAD, the specific mechanism of elevated CRP in CAD is not known. One possible etiology includes a continuous prothrombotic process associated with CAD. Several studies demonstrate a link between platelet activation and inflammation. If thrombotic processes are involved in the mechanism of elevated CRP, antiplatelet therapy, including clopidogrel, could effectively reduce CRP. Preliminary studies have demonstrated a reduction of CRP with aspirin and a clear association between clopidogrel therapy and reduced CRP, however no randomized trials have been performed. We hypothesize that the proinflammatory effects of platelet activation may be inhibited with combined clopidogrel and aspirin therapy.

Detailed description

The objective of this trial is to assess the effects of combined therapy of clopidogrel and aspirin versus placebo and aspirin on CRP in patients with known CAD. Potential subjects already on stable aspirin and statin therapy will be randomized to clopidogrel vs. placebo in a I: 1 design. Participants will undergo study therapy for 3 months. Various laboratory parameters, including serum plasma concentration of CRP, will be assessed throughout the study. The primary endpoint is the effect of study therapy on CRP.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	aspirin
DRUG	clopidogrel

Timeline

• Start date: 2005-07-01
• Completion: 2006-11-01
• First posted: 2006-06-23
• Last updated: 2008-08-21

Locations

1 site across 1 country: United States