Condition category
Circulatory System
Date applied
13/12/2009
Date assigned
06/01/2010
Last edited
19/05/2011
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

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect 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

Acronym

CASSANDRA

Study hypothesis

Treatment with clopidogrel 75 mg per day improves brachial artery flow-mediated dilation of patients with coronary artery disease.

Ethics approval

Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 20th December 2004

Study design

Prospective double-blind randomised single-centre three-armed phase IV clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stable coronary artery disease

Intervention

Clopidogrel 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 type

Drug

Phase

Phase IV

Drug names

Clopidogrel, acetylsalicylic acid (ASA)

Primary outcome measures

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

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.

Overall trial start date

10/04/2006

Overall trial end date

06/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

10/04/2006

Recruitment end date

06/06/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Medicine II
Mainz
55131
Germany

Sponsor information

Organisation

Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)

Sponsor details

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20644943

Publication citations

  1. Results

    Ostad MA, Nick E, Paixao-Gatinho V, Schnorbus B, Schiewe R, Tschentscher P, Munzel T, Warnholtz A, Lack of evidence for pleiotropic effects of clopidogrel on endothelial function and inflammation in patients with stable coronary artery disease: results of the double-blind, randomized CASSANDRA study., Clin Res Cardiol, 2011, 100, 1, 29-36, doi: 10.1007/s00392-010-0199-6.

Additional files

Editorial Notes