Condition category
Circulatory System
Date applied
30/11/2006
Date assigned
06/12/2006
Last edited
06/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ascan Warnholtz

ORCID ID

Contact details

Johannes Gutenberg-Universität Mainz
Department of Medicine II
Langenbeckstrasse 1
Mainz
55101
Germany

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

http://www.klinik.uni-mainz.de/2-Med/

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

Publication citations

Additional files

Editorial Notes