Brain IschemiaPhase 4NCT00161070
ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
A Phase 4 study testing anticoagulation, aspirin and dipyridamole and aspirin alone in people with Brain Ischemia and Transient Ischemic Attack, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Ischemia, Transient Ischemic Attack, Arteriosclerosis
- What is being tested?
- anticoagulation, aspirin and dipyridamole and aspirin alone
- How many people
- 4,500 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 1997to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting in the participating hospitals with a TIA or non-disabling stroke of atherosclerotic origin
- Randomisation within 6 months after the TIA or minor stroke
- Modified Rankin scale of 3 or less
Who cannot join
- (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
- Disease expected to cause death within weeks or months
- Source of embolism in the heart
- Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
- Anemia, polycythemia, thrombocytosis, or thrombocytopenia
- Planned carotid endarterectomy
Show all 12Show fewer
- Intracranial bleeding or cerebral tumour
- TIA or stroke caused by vasculitis, migraine, or dissection
- Severe hypertension
- Liver failure
- Pregnancy
- Chronic alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.
Read the detailed description
Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.
Study design: ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:
- oral AC (INR 2.0 to 3.0);
- the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or
- ASA only (same dose).
The mean follow-up was three years. Primary outcome was the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.
- Conditions
- Brain Ischemia, Transient Ischemic Attack, Arteriosclerosis
- Being tested
- anticoagulation, aspirin and dipyridamole, aspirin alone
- Keywords
- secondary prevention, TIA / minor stroke, atherosclerotic origin, TIA (Transient Ischemic Attack), prevention & control
- Medical subject headings
- Brain Ischemia, Ischemic Attack, Transient, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulationDrug
aspirin and dipyridamoleDrug
aspirin aloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
Secondary outcomes (8)
Death from all causes
death from vascular causes
death from vascular causes or nonfatal stroke
fatal or nonfatal stroke
death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
major bleeding complications
amputations of lower extremities
retinal infarction or bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 1997
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,500 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- A. Algra, Professor, Principal investigator, UMC UtrechtJ. Gijn Van, Professor, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161070
- Sponsor's protocol ID
- 96-217
- Other IDs
- Heart Found.: 97.026, Eur. Com.: QLK6-CT-2002-02332
- Status last verified
- Mar 2007
- First submitted
- 8 Sep 2005
- Last updated
- 22 Mar 2007
- Results posted
- No
Publications
ESPRIT Study Group; 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 May 20;367(9523):1665-73. doi: 10.1016/S0140-6736(06)68734-5.
PubMed 16714187ESPRIT Study Group; Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial. Lancet Neurol. 2007 Feb;6(2):115-24. doi: 10.1016/S1474-4422(06)70685-8.
PubMed 17239798Narasimhalu K, Ang S, De Silva DA, Wong MC, Chang HM, Chia KS, Auchus AP, Chen CP. The prognostic effects of poststroke cognitive impairment no dementia and domain-specific cognitive impairments in nondisabled ischemic stroke patients. Stroke. 2011 Apr;42(4):883-8. doi: 10.1161/STROKEAHA.110.594671. Epub 2011 Feb 17.
PubMed 21330625
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
- ClinicalTrials.gov ID
- NCT00161070
- Acronym / sponsor ID
- 96-217
- Conditions
- Brain Ischemia, Transient Ischemic Attack, Arteriosclerosis
- Keywords
- secondary prevention, TIA / minor stroke, atherosclerotic origin, TIA (Transient Ischemic Attack), prevention & control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,500 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jul 1997
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.
Detailed description
Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.
Study design: ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:
- oral AC (INR 2.0 to 3.0);
- the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or
- ASA only (same dose).
The mean follow-up was three years. Primary outcome was the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting in the participating hospitals with a TIA or non-disabling stroke of atherosclerotic origin
- Randomisation within 6 months after the TIA or minor stroke
- Modified Rankin scale of 3 or less
Key exclusion criteria (12 listed)
- (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
- Disease expected to cause death within weeks or months
- Source of embolism in the heart
- Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
- Anemia, polycythemia, thrombocytosis, or thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anticoagulation | Drug | – |
| aspirin and dipyridamole | Drug | – |
| aspirin alone | Drug | – |
Primary outcome
The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
8 secondary outcomes
Death from all causes
death from vascular causes
death from vascular causes or nonfatal stroke
fatal or nonfatal stroke
death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
major bleeding complications
amputations of lower extremities
retinal infarction or bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2007.
- Results publication: PubMed 16714187ESPRIT Study Group; 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 May 20;367(9523):1665-73. doi: 10.1016/S0140-6736(06)68734-5.
- Results publication: PubMed 17239798ESPRIT Study Group; Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial. Lancet Neurol. 2007 Feb;6(2):115-24. doi: 10.1016/S1474-4422(06)70685-8.
- Derived from this study: PubMed 21330625Narasimhalu K, Ang S, De Silva DA, Wong MC, Chang HM, Chia KS, Auchus AP, Chen CP. The prognostic effects of poststroke cognitive impairment no dementia and domain-specific cognitive impairments in nondisabled ischemic stroke patients. Stroke. 2011 Apr;42(4):883-8. doi: 10.1161/STROKEAHA.110.594671. Epub 2011 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Algra, Professor principal investigator
UMC Utrecht
J. Gijn Van, Professor principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anticoagulation, aspirin and dipyridamole and aspirin alone in people with Brain Ischemia and Transient Ischemic Attack, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00161070, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2007.