European/Australasian Stroke Prevention in Reversible Ischaemia Trial
| ISRCTN | ISRCTN73824458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73824458 |
| ClinicalTrials.gov number | NCT00161070 |
| Secondary identifying numbers | N/A |
- 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
Scientific
University Medical Center Utrecht
PO Box 85500
Mailbox STR 6.131
Utrecht
3508 GA
Netherlands
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aspirin, dipyridamole |
| Primary outcome measure | 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 study start date | 01/07/1997 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2,739 |
| 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
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
PO Box 85500
Room H.02.128
Utrecht
3508 GA
Netherlands
| Phone | +31 30 2508350 |
|---|---|
| p.h.a.halkes@neuro.azu.nl | |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Other
Netherlands Heart Foundation (Netherlands)
No information available
UK Stroke Association (UK)
No information available
University Medical Center Utrecht (Netherlands)
No information available
Janivo Foundation (Netherlands)
No information available
French Ministry of Health (France)
No information available
Netherlands Thrombosis Foundation (Netherlands)
No information available
European Commission (ref: QLK6-CT-2002-02332)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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
