NO BLEeding excess with antiplatelet treatment with thromboserin during coronary artery bypass grafting (CABG)
| ISRCTN | ISRCTN59071456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59071456 |
| Secondary identifying numbers | 6930; RC-PG-0308-10210 |
- Submission date
- 30/07/2010
- Registration date
- 30/07/2010
- Last edited
- 30/11/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mark Noble
Scientific
Scientific
Department of Medicine and Therapeutics
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZH
United Kingdom
Study information
| Study design | Single centre randomised interventional treatment trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | As approved by REC |
| Scientific title | |
| Study acronym | NO BLEeding during CABG (NOBLE 2) |
| Study objectives | Objective: To evaluate whether activation of thrombosis by cardiac surgery is modified by means of serotonin 5HT2A receptor antagonism. Study population: 60 patients with a history of coronary artery disease scheduled for coronary artery bypass grafting (CABG). Patients have clinical and investigative findings of critical coronary artery stenoses requiring revascularisation. Study design: Randomised controlled double blind study: patients randomised to placebo or thromboserin 10 mg stat followed by 5 mg twice daily (bd). Study duration is 12 months. The drug supply has MHRA approval. Please note that as of 25/01/2011 this trial has never started and is currently on hold pending review of the protocol with the sponsor. |
| Ethics approval(s) | MREC approved (ref: 08/H0806/91) |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | Placebo or thromboserin 10 mg stat followed by 5 mg bd. Total duration of 12 months. Please note, this trial never started as the objectives were no longer viable. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Thromboserin |
| Primary outcome measure | Platelet aggregate and thrombus growth |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2009 |
| Completion date | 28/02/2011 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 120 |
| Key inclusion criteria | The original protocol, which received ethical and MHRA approval states. All patients requiring cardiac surgery. |
| Key exclusion criteria | The original protocol, which received ethical and MHRA approval states. Patients with bradycardia or bradyarrhythmia, unless drug induced and the drug stopped (e.g. ß- adrenoreceptor antagonists). Patients treated with serotonin re-uptake inhibitors. |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Medicine and Therapeutics,
Aberdeen
AB25 2ZH
United Kingdom
AB25 2ZH
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Claybrook Centre
37 Claybrook Road
London
W6 8LN
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) programme
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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
