European/Australasian Stroke Prevention in Reversible Ischaemia Trial

ISRCTN	ISRCTN73824458
DOI	https://doi.org/10.1186/ISRCTN73824458
ClinicalTrials.gov (NCT)	NCT00161070
Protocol serial number	N/A
Sponsor	University Medical Center Utrecht (Netherlands)
Funders	Netherlands Heart Foundation (Netherlands), UK Stroke Association (UK), University Medical Center Utrecht (Netherlands), Janivo Foundation (Netherlands), French Ministry of Health (France), Netherlands Thrombosis Foundation (Netherlands), European Commission (ref: QLK6-CT-2002-02332)

Submission date: 23/06/2004
Registration date: 28/09/2004
Last edited: 08/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ale Algra
Scientific

University Medical Center Utrecht
PO Box 85500
Mailbox STR 6.131
Utrecht
3508 GA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	European/Australasian Stroke Prevention in Reversible Ischaemia Trial: ESPIRIT
Study acronym	ESPRIT
Study objectives	Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. The aim of the study is to resolve this uncertainty.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ischaemia
Intervention	Secondary prevention after transient ischaemic attack or non-disabling ischaemic stroke. Three treatment strategies: 1. Oral anticoagulation (international normalised ratio [INR] 2.0-3.0) 2. The combination of aspirin (acetylsalicylic acid [ASA]) (in any dose between 30 mg and 325 mg daily) and dipyridamole (400 mg daily) 3. ASA (in any dose between 30 mg and 325 mg daily)
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aspirin, dipyridamole
Primary outcome measure(s)	Composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first.
Key secondary outcome measure(s)	1. Death from all causes 2. Death from vascular causes 3. Death from vascular causes or nonfatal stroke 4. Fatal or nonfatal stroke 5. Death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention 6. Major bleeding complications 7. Amputations of lower extremities 8. Retinal infarction or bleeding
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2739
Key inclusion criteria	1. Patients presenting in the participating hospitals with a transient ischaemic attack (TIA) or non-disabling stroke of atherosclerotic origin 2. Randomisation within 6 months after the TIA or minor stroke 3. Modified Rankin scale of 3 or less
Key exclusion criteria	1. (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin 2. Disease expected to cause death within weeks or months 3. Source of embolism in the heart 4. Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis) 5. Anemia, polycythemia, thrombocytosis, or thrombocytopenia 6. Planned carotid endarterectomy 7. Intracranial bleeding or cerebral tumour 8. TIA or stroke caused by vasculitis, migraine, or dissection 9. Severe hypertension 10. Liver failure 11. Pregnancy 12. Chronic alcohol abuse
Date of first enrolment	01/07/1997
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/05/2006		Yes	No
Results article	results	29/05/2012		Yes	No

Editorial Notes

08/05/2020: Internal review