NO BLEeding excess with antiplatelet treatment with thromboserin during coronary artery bypass grafting (CABG)

ISRCTN	ISRCTN59071456
DOI	https://doi.org/10.1186/ISRCTN59071456
Protocol serial number	6930; RC-PG-0308-10210
Sponsor	Imperial College London (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) programme

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

Department of Medicine and Therapeutics
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZH
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Thromboserin
Primary outcome measure(s)	Platelet aggregate and thrombus growth
Key secondary outcome measure(s)	Not provided at time of registration
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 sample size at registration	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

United Kingdom
Scotland

Study participating centre

Department of Medicine and Therapeutics,

Aberdeen
AB25 2ZH
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?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes