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Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery

NCT01466452 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2011-11-08

No results posted yet for this study

Summary

This study is a randomized open label study that implies the administration of asprin according to three different regimens.

The aims of the study are:

* to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
* to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.

The endpoints of this study are:

\- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin

Conditions

  • Coronary Arteriosclerosis

Interventions

DRUG

Aspirin

single-dose aspirin in 100 mg 1 tablet every 24 hours

DRUG

Aspirin

single-dose aspirin 200 mg 1 tablet every 24 hours

DRUG

Aspirin

double-dose aspirin 100 mg 1 tablet every 12 hours

Sponsors & Collaborators

  • Catholic University, Italy

    collaborator OTHER

  • University of Chieti

    collaborator OTHER

  • Centro Cardiologico Monzino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466452 on ClinicalTrials.gov