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

ISRCTN ISRCTN34097747
DOI https://doi.org/10.1186/ISRCTN34097747
Protocol serial number N/A
Sponsor Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)
Funder Bristol-Myers Squibb GmbH & Co. KGaA (Germany)
Submission date
13/12/2009
Registration date
06/01/2010
Last edited
19/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ascan Warnholtz
Scientific

Department of Medicine II
Johannes Gutenberg-University Mainz
Langenbeckstrasse 1
Mainz
55131
Germany

Study information

Primary study designInterventional
Study designProspective double-blind randomised single-centre three-armed phase IV clinical trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEffect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease: a prospective, double-blind, randomised, single-centre trial
Study acronymCASSANDRA
Study objectivesTreatment with clopidogrel 75 mg per day improves brachial artery flow-mediated dilation of patients with coronary artery disease.
Ethics approval(s)Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 20th December 2004
Health condition(s) or problem(s) studiedStable coronary artery disease
InterventionClopidogrel 75 mg per day versus clopidogrel 75 mg and acetylsalicylic acid 100 mg per day versus acetylsalicylic acid 100 mg per day for 4 weeks.
Intervention typeDrug
PhasePhase IV
Drug / device / biological / vaccine name(s)Clopidogrel, acetylsalicylic acid (ASA)
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Effects of treatment on:
1. Platelet superoxide production
2. Adenosine diphosphate (ADP)-induced platelet aggregation
3. Nitroglycerin-induced brachial artery dilation
4. Inflammatory markers

Evaluated by measurements at the beginning of the trial and at the end of treatment at day 28.

Completion date06/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/04/2006
Date of final enrolment06/06/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Medicine II
Mainz
55131
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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