Is cessation of clopidogrel therapy associated with rebound of platelet activity in stable vascular disease patients?
| ISRCTN | ISRCTN77887299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77887299 |
| EudraCT/CTIS number | 2007-007638-21 |
| Secondary identifying numbers | Protocol 2.1 |
- Submission date
- 10/02/2009
- Registration date
- 21/04/2009
- Last edited
- 12/11/2013
- 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
Ms Julie Brittenden
Scientific
Scientific
Ward 36
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Is cessation of clopidogrel therapy associated with rebound of platelet activity in stable vascular disease patients? - a randomised double-blind placebo-controlled trial |
| Study acronym | CLASP |
| Study objectives | The primary aim of this clinical trial is to identify whether there is evidence for a "rebound" effect on platelet markers associated with cessation of clopidogrel therapy. We propose to address this in patients with stable cardiovascular disease by means of a mechanistic study. |
| Ethics approval(s) | North of Scotland Research Ethics Committee, approved on 07/07/2008 (ref: 08/S0801/87) |
| Health condition(s) or problem(s) studied | Cardiovascular and peripheral vascular disease |
| Intervention | We aim to test 78 subjects in each treatment arm over a period of 2 years. Participants will be allocated to either: I. Clopidogrel (oral) 75 mg daily for 30 days, or II. Placebo (oral) 75 mg daily for 30 days On day 31, all participants will stop taking the study drugs but will continue to take their usual medications including aspirin. They will be studied for a further month, testing at 7, 14 and 28 days after stopping clopidogrel or placebo. Total duration of study = 2 months per participant. |
| Intervention type | Other |
| Primary outcome measure | Measurement of platelet activation and aggregation, before treatment, on clopidogrel/placebo, and at 7, 14 and 28 days after cessation of clopidogrel/placebo. |
| Secondary outcome measures | The following inflammatory and procoagulant markers will be assessed before treatment, on clopidogrel/placebo, and at 7, 14 and 28 days after cessation of clopidogrel/placebo: 1. High-sensitivity C-reactive protein (hs-CRP) 2. D-Dimer 3. Soluble CD40 (sCD40) ligand 4. Soluble P-selectin (sP-selectin) While the primary aim of this study is not to measure clinical outcome, such data will be collected in order to inform a later multi-centre clinical outcome study. |
| Overall study start date | 26/11/2008 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 156 |
| Key inclusion criteria | 1. Both males and females, age 30-80 years 2. Evidence of chronic atherosclerotic disease - stable coronary heart disease or peripheral arterial disease 3. Already receiving standard secondary prevention therapy for cardiovascular disease, including aspirin therapy and a statin 4. Able to give informed consent |
| Key exclusion criteria | 1. Known allergy to clopidogrel 2. Contraindications to clopidogrel as listed in the Summary of Product 3. Characteristics for clopidogrel (i.e Hypersensitivity to the active substance or to any of the excipients of the medicinal product, severe liver impairment, active pathological bleeding such as peptic ulcer or intracranial haemorrhage, breast feeding) Also: 4. History of thrombocytopenia, neutropenia or haematological malignancy 5. Bleeding diathesis 6. Abnormal renal or hepatic function 7. Transfusion of whole blood cells within 14 days prior to randomisation 8. Known or suspected drug or alcohol abuse 9. Clinical symptoms of heart failure 10. Women of child-bearing potential 11. Taking anticoagulant or antiplatelet drugs other than aspirin 12. Participation in another clinical trial of a medicinal product (CTIMP) within preceding 3 months |
| Date of first enrolment | 26/11/2008 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Ward 36
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
Grampian Health Board and University of Aberdeen (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Foresterhill Annex
Foresterhill
Aberdeen
AB25 2ZN
Scotland
United Kingdom
| mmd175@abdn.ac.uk | |
| Website | http://www.nhsgrampian.org |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Charity
Heart Research UK (UK) (ref: RG2555/08/10) - main funder
No information available
UK Clinical Research Collaboration (UKCRC) via the Chief Scientist Office (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/01/2014 | Yes | No |
