Condition category
Circulatory System
Date applied
26/08/2005
Date assigned
28/10/2005
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philip Bath

ORCID ID

Contact details

Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4792
philip.bath@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Triple 2

Study hypothesis

We hypothesise that combination therapy with three antiplatelet agents that act through different mechanisms may maximise the benefit of antiplatelet treatment in the secondary prevention of stroke, both in patients with sinus rhythm and those with stroke who cannot be anticoagulated.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Ischaemic stroke

Intervention

Combined aspirin (75 mg once a day [od], A), dipyridamole (200 mg twice a day [bd], B) and clopidogrel (75 mg od, C) versus aspirin (75 mg od, A) alone.

Intervention type

Drug

Phase

Not Specified

Drug names

Aspirin, clopidogrel, dipyridamole

Primary outcome measures

Number of subjects completing randomised treatment to final follow up.

Secondary outcome measures

1. Recurrent ischaemic stroke or TIA
2. Intracerebral haemorrhage
3. Major extracranial bleeding
4. Minor extracranial bleeding (epistaxis, purpura)
5. Sitting and standing blood pressure (BP), heart rate at 2 weeks, 3 months and follow up
6. Presence of headache

Overall trial start date

26/10/2001

Overall trial end date

28/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Ischaemic stroke on computed tomography (CT)/magnetic resonance imaging (MRI) within 5 years
3. Previous transient ischemic attack (TIA) within 5 years
4. Written informed consent from patient
5. In sinus ryhthm or atrial fibrillation but not suitable for anticoagulation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

51

Participant exclusion criteria

1. Thrombocytopenia
2. Severe hypertension
3. Previous cerebral haemorrhage
4. Hypersensitivity or intolerance to aspirin, dipyridamole or clopidogrel
5. Any history of peptic ulcer or gastrointestinal bleeding
6. Severe concomitant medical conditions including acquired immunodeficiency syndrome (AIDS) or cancer
7. Pregnancy or breast feeding
8. Patients needing or already receiving anticoagulant or non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin therapy

Recruitment start date

26/10/2001

Recruitment end date

28/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Stroke Medicine
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4791
philip.bath@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18682741

Publication citations

  1. Results

    Sprigg N, Gray LJ, England T, Willmot MR, Zhao L, Sare GM, Bath PM, A randomised controlled trial of triple antiplatelet therapy (aspirin, clopidogrel and dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility., PLoS ONE, 2008, 3, 8, e2852, doi: 10.1371/journal.pone.0002852.

Additional files

Editorial Notes