Optimum platelet inhibition after coronary artery bypass surgery: a prospective, randomised trial comparing platelet aggregation using low- and medium-dose aspirin and clopidogrel
| ISRCTN | ISRCTN55334531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55334531 |
| Protocol serial number | N0542115296 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Papworth Hospital NHS Trust (UK) - Papworth Hospital Charitable Funds |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Stephen Large
Scientific
Scientific
Surgical Unit Top Floor
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine the most effective anti-platelet agent following coronary artery by pass grafting (CABG). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coronary artery bypass grafting (CABG) |
| Intervention | Patients will be randomised into treatment allocation to receive either 100 mg aspirin, 325 mg aspirin or identically encapsulated 75 mg clopidogrel daily for 5 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | Platelet aggregation ratio at 5 days. |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 108 |
| Key inclusion criteria | 72 Patients and 36 controls will be recruited from patients proceeding to coronary artery bypass surgery. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 28/08/2002 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Surgical Unit Top Floor
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2004 | Yes | No |