Condition category
Circulatory System
Date applied
23/06/2004
Date assigned
28/09/2004
Last edited
12/08/2013
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

Dr Ale Algra

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00161070

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ESPRIT

Study hypothesis

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

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

Treatment

Patient information sheet

Condition

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 names

Aspirin, dipyridamole

Primary outcome measures

Composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first.

Secondary outcome measures

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

Overall trial start date

01/07/1997

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,739

Participant 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

Recruitment start date

01/07/1997

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (Netherlands)

Sponsor details

PO Box 85500
Room H.02.128
Utrecht
3508 GA
Netherlands
+31 30 2508350
p.h.a.halkes@neuro.azu.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Netherlands Heart Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UK Stroke Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Medical Center Utrecht (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janivo Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

French Ministry of Health (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Thrombosis Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission (ref: QLK6-CT-2002-02332)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16714187
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22642755

Publication citations

  1. Results

    , Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A, Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial., Lancet, 2006, 367, 9523, 1665-1673, doi: 10.1016/S0140-6736(06)68734-5.

  2. Results

    Leslie WS, Koshy PR, Mackenzie M, Murray HM, Boyle S, Lean ME, Walker A, Hankey CR, Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial., BMC Public Health, 2012, 12, 389, doi: 10.1186/1471-2458-12-389.

Additional files

Editorial Notes