Effect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease

Completed

• Conditions: Circulatory System; Stable coronary artery disease; Chronic ischaemic heart disease

• Registration Number: ISRCTN34097747
• Lead Sponsor: Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Men or women, older than 18 years of age
2. Angiographically documented coronary artery disease
3. Absence of angina pectoris within the previous four weeks
4. Written informed consent must be available before enrolment in the trial

Exclusion Criteria

1. Stroke or peripheral arterial revascularisation within the previous 12 weeks
2. Clopidogrel intolerance
3. Planned coronary stent implantation within the next 6 weeks
4. Haemodynamically significant valvular heart disease
5. Known hyper- or hypothyroidism
6. Renal dysfunction (creatinine more than 2.0 mg/dl)
7. Chronic inflammatory intestinal disease or history of malabsorption
8. History of chronic liver disease or pancreatitis
9. Existence of acute gastric ulcers or acute gastrointestinal bleeding
10. Haemoglobin less than 12 g/dl, white blood cells (WBC) less than 4/nl or platelet count less than 100/nl
11. History of organ transplantation
12. Anticipated non-compliance with the protocol
13. Pregnancy
14. Participation in another clinical trial
15. Clinical signs of congestive heart failure or left ventricular ejection fraction less than 40%
16. Uncontrolled hypertension (blood pressure more than 180/105 mmHg)
17. Orthostatic hypotension (supine systolic blood pressure less than 90 mmHg)
18. Treatment with clopidogrel or ticlopidine within the last 28 days prior to study start
19. Initiation of treatment with angiotensin converting enzyme (ACE) inhibitor, statin or calcium channel blocker within previous 2 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of treatment on the absolute change in % flow-mediated dilation (FMD) of the right brachial artery. Evaluated by measurements at the beginning of the trial and at the end of treatment at day 28.

Secondary Outcome Measures

Name	Time	Method
Effects of treatment on: <br>1. Platelet superoxide production <br>2. Adenosine diphosphate (ADP)-induced platelet aggregation<br>3. Nitroglycerin-induced brachial artery dilation<br>4. Inflammatory markers<br><br>Evaluated by measurements at the beginning of the trial and at the end of treatment at day 28.