Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6930; RC-PG-0308-10210
Study information
Scientific title
Acronym
NO BLEeding during CABG (NOBLE 2)
Study hypothesis
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
MREC approved (ref: 08/H0806/91)
Study design
Single centre randomised interventional treatment trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
As approved by REC
Condition
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 names
Thromboserin
Primary outcome measures
Platelet aggregate and thrombus growth
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2009
Overall trial end date
28/02/2011
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
The original protocol, which received ethical and MHRA approval states. All patients requiring cardiac surgery.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 120
Participant 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.
Recruitment start date
01/01/2009
Recruitment end date
28/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine and Therapeutics,
Aberdeen
AB25 2ZH
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Claybrook Centre
37 Claybrook Road
London
W6 8LN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) programme
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