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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aspirin
clopidogrel
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring hs-CRP, aspirin, clopidogrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Either gender > 18 years of age Documented coronary artery disease (CAD) of~ 70% documented lesion Must be taking 325 mg/day of aspirin (preferably Ecotrin)and a statin at least 4 weeks prior to enrollment The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board Able to give informed consent Exclusion Criteria: Documented sensitivity to aspirin or clopidogrel Uncontrolled hypertension as determined by the investigator Known bleeding disorder or increased risk of bleeding such as: severe hepatic, insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of bleeding diathesis or coagulopathy History of severe systemic bleeding such as: gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage Hospitalization for any MI or unstable angina in last 90 days Scheduled for a major surgery requiring prolonged study drug cessation (more than 4 weeks) Currently taking a thienopyridine agent (clopidogrel or ticlopidine), oral GP IIb/IIIa inhibitor, oral anticoagulant, or dipyridamole Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.

Sites / Locations

  • LDS Hospital

Outcomes

Primary Outcome Measures

The primary endpoint is the observation of the effect of aspirin + clopidogrel vs.
aspirin + placebo on CRP levels.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2006
Last Updated
August 20, 2008
Sponsor
Intermountain Health Care, Inc.
Collaborators
Bristol-Myers Squibb, Sanofi-Synthelabo
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1. Study Identification

Unique Protocol Identification Number
NCT00343876
Brief Title
Clopidogrel and Aspirin Together: The Effect on C-Reactive Protein Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Bristol-Myers Squibb, Sanofi-Synthelabo

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
hs-CRP, aspirin, clopidogrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Primary Outcome Measure Information:
Title
The primary endpoint is the observation of the effect of aspirin + clopidogrel vs.
Title
aspirin + placebo on CRP levels.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Either gender > 18 years of age Documented coronary artery disease (CAD) of~ 70% documented lesion Must be taking 325 mg/day of aspirin (preferably Ecotrin)and a statin at least 4 weeks prior to enrollment The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board Able to give informed consent Exclusion Criteria: Documented sensitivity to aspirin or clopidogrel Uncontrolled hypertension as determined by the investigator Known bleeding disorder or increased risk of bleeding such as: severe hepatic, insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of bleeding diathesis or coagulopathy History of severe systemic bleeding such as: gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage Hospitalization for any MI or unstable angina in last 90 days Scheduled for a major surgery requiring prolonged study drug cessation (more than 4 weeks) Currently taking a thienopyridine agent (clopidogrel or ticlopidine), oral GP IIb/IIIa inhibitor, oral anticoagulant, or dipyridamole Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph B Muhlestein, MD
Organizational Affiliation
Intermountain Healthcare, LDS Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

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

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