NCT00161070

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 22, 2007

Status Verified

March 1, 2007

First QC Date

September 8, 2005

Last Update Submit

March 21, 2007

Conditions

Brain IschemiaTransient Ischemic AttackArteriosclerosis

Keywords

secondary preventionTIA / minor strokeatherosclerotic originTIA (Transient Ischemic Attack)prevention & control

Outcome Measures

Primary Outcomes (1)

  • 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

  • +3 more secondary outcomes

Interventions

anticoagulationDRUG
aspirin and dipyridamoleDRUG
aspirin aloneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • (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
  • Intracranial bleeding or cerebral tumour
  • TIA or stroke caused by vasculitis, migraine, or dissection
  • Severe hypertension
  • Liver failure
  • Pregnancy
  • Chronic alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 16714187RESULT

  • ESPRIT 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.

    PMID: 17239798RESULT

  • Narasimhalu 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.

    PMID: 21330625DERIVED

MeSH Terms

Conditions

Brain IschemiaIschemic Attack, TransientArteriosclerosis

Interventions

AspirinDipyridamole

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • A. Algra, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • J. Gijn Van, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

July 1, 1997

Study Completion

December 1, 2006

Last Updated

March 22, 2007

Record last verified: 2007-03

Locations

NL(1)