Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CLEOPATRA
Study hypothesis
One single dose of clopidogrel causes dose-dependent improvement of flow-mediated dilation to the right brachial artery in patients with stable coronary artery disease.
Ethics approval
Approval received from the local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz), dated Dec 20th, 2004 (ref: 837.473.04 [4631]).
Study design
A prospective, double-blind, randomised, single-center, two-armed clinical trial of phase IV.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Stable coronary artery disease
Intervention
Single dose of 300 mg versus 600 mg of clopidogrel orally.
Intervention type
Drug
Phase
Phase IV
Drug names
Clopidogrel
Primary outcome measures
Effect of treatment on the absolute change in % Flow-Mediated Dilation (FMD).
Secondary outcome measures
Effects of treatment on:
1. Platelet superoxide production
2. Platelet basal VAsodilator-Stimulated Phosphoprotein (VASP)-phosphorylation
3. Platelet P2V12-receptor inhibition
Overall trial start date
01/03/2005
Overall trial end date
02/02/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
58
Participant 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
Recruitment start date
01/03/2005
Recruitment end date
02/02/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Johannes Gutenberg-Universität Mainz
Mainz
55101
Germany
Sponsor information
Organisation
Johannes Gutenberg-Universität Mainz (Germany)
Sponsor details
c/o Prof. Dr. T. Münzel
Department of Medicine II
Langenbeckstrasse 1
Mainz
55101
Germany
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Bristol-Myers Squibb GmbH & Co. KGaA (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary