Effect of clopidogrel loading dose on brachial flow mediated vasodilation in patients with coronary artery disease

Completed

Conditions: Stable coronary artery disease
Circulatory System
Ischaemic heart diseases

Registration Number: ISRCTN17892444

Lead Sponsor: Johannes Gutenberg-Universität Mainz (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 58

Inclusion Criteria

1. Men or women, older than 18 years of age
2. Angiographically documented, clinically stable coronary artery disease (defined as at least one coronary artery stenosis more than 50% or general wall irregularities)
3. Endothelial dysfunction, defined as a Flow-Mediated Vasodilatation (FMD) of less than 8%
4. Ability of subject to understand character and individual consequences of clinical trial
5. Written informed consent must be available before enrolment in the trial
6. Current therapy with acetylsalicylic acid 100 mg/d

Exclusion Criteria

1. Acute coronary syndrome
2. Clinical signs of congestive heart failure or left ventricular ejection fraction less than 40%
3. Uncontrolled hypertension (blood pressure more than 180/105 mmHg) or hypotension (systolic blood pressure less than 90 mmHg)
4. Treatment with clopidogrel or ticlopidine within the last 28 days prior to study start
5. Haemodynamically significant valvular heart disease
6. Renal dysfunction (creatinine more than 2.0 mg/dl)
7. History of chronic liver disease or pancreatitis
8. Alcohol abuse
9. Haemoglobin less than 12 g/dl, White Blood Cells (WBC) less than 4/nl or platelet count less than 100/nl
10. Existence of acute gastric ulcers or acute gastrointestinal bleeding
11. Chronic inflammatory intestinal disease or history of malabsorption
12. Known hyper- or hypothyroidism
13. Anticipated non-compliance with the protocol
14. Pregnancy
15. Participation in another clinical trial

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).

Secondary Outcome Measures

Name	Time	Method
Effects of treatment on:<br>1. Platelet superoxide production<br>2. Platelet basal VAsodilator-Stimulated Phosphoprotein (VASP)-phosphorylation <br>3. Platelet P2V12-receptor inhibition