NCT00000527

Brief Summary

To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1986

Longer than P75 for phase_2 cardiovascular-diseases

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

August 1, 1986

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1998

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

12.3 years

First QC Date

October 27, 1999

Last Update Submit

December 9, 2013

Conditions

Cardiovascular DiseasesCarotid StenosisCerebrovascular DisordersHeart DiseasesVascular Diseases

Interventions

aspirinDRUG
dipyridamoleDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women who had recently undergone carotid endarterectomy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • Harker LA. Role of platelets and thrombosis in mechanisms of acute occlusion and restenosis after angioplasty. Am J Cardiol. 1987 Jul 31;60(3):20B-28B. doi: 10.1016/0002-9149(87)90479-6.

    PMID: 2956836BACKGROUND

  • Harker LA: The Use of Agents That Modify Platelet Function in the Management of Thrombotic Disorders. In: Hemostasis and Thrombosis, 2nd Edition, Colman RW et al (eds), Philadelphia, JB Lippincott Co, pp. 1438-1456, 1987.

    BACKGROUND

  • Scharf RE, Harker LA. Thrombosis and atherosclerosis: regulatory role of interactions among blood components and endothelium. Blut. 1987 Sep;55(3):131-44. doi: 10.1007/BF00320567.

    PMID: 3304475BACKGROUND

  • Harker LA, Hanson SR: Antithrombotic Strategies in Peripheral Arterial Disease. In: Vascular Diseases Current Research and Clinical Applications, Strandness DE Jr, et al (eds), Grune & Stratton, Inc., pp. 271-283, 1987.

    BACKGROUND

  • Harker LA: Antithrombic Therapy in Patients with Transient Ischemic Attacks or Amaurosis Fugax. In: Amaurosis Fugax, Bernstein EF (ed), New York, Springer-Verlag, pp. 110-118, 1988.

    BACKGROUND

  • Harker LA, Bernstein EF, Dilley RB, Scala TE, Sise MJ, Hye RJ, Otis SM, Roberts RS, Gent M. Failure of aspirin plus dipyridamole to prevent restenosis after carotid endarterectomy. Ann Intern Med. 1992 May 1;116(9):731-6. doi: 10.7326/0003-4819-116-9-731.

    PMID: 1558344BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCarotid StenosisCerebrovascular DisordersHeart DiseasesVascular Diseases

Interventions

AspirinDipyridamole

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1986

Primary Completion

November 1, 1998

Study Completion

November 1, 1998

Last Updated

December 11, 2013

Record last verified: 2013-12