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

Coronary Arteriosclerosis Clinical Trial

— ASABYVALV  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01466452
• Other study ID #: S181/211
• Status: Recruiting
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: November 7, 2011
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2011
• Source: Centro Cardiologico Monzino
• Contact: Alessandro Parolari, MD PhD
• Phone: +39 025800
• Email: alessandro.parolari[@]ccfm.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• informed consent of the study signed

• coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses

• age between 55 and 80

• ejection fraction > 30%.

Exclusion Criteria:

• excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding

• perioperative myocardial infarction

• stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation

• patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention

• patients undergoing off-pump coronary artery bypass graft

• overt kidney or liver disease

• therapies that influence the coagulation

• fertile women

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin
single-dose aspirin in 100 mg 1 tablet every 24 hours
• Aspirin
single-dose aspirin 200 mg 1 tablet every 24 hours
• Aspirin
double-dose aspirin 100 mg 1 tablet every 12 hours

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, IRCCS	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Catholic University, Italy, University of Chieti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin		one year	Yes
Primary	change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin		one year	Yes
Secondary	change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin		one year	Yes
Secondary	change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin		one year	Yes
Secondary	change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin		one year	Yes
Secondary	change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin		one year	Yes