Condition category
Circulatory System
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
30/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Noble

ORCID ID

Contact details

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

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

http://www3.imperial.ac.uk/

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

Publication citations

Additional files

Editorial Notes