NCT01466452

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-11-08
• Last updated: 2011-11-08

Locations

1 site across 1 country: Italy