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

• Sponsor: Centro Cardiologico Monzino (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01466452
• Collaborator: Catholic University, Italy (Other), University of Chieti (Other)
• Enrollment: 99
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteriosclerosis	Drug: Aspirin; Drug: Aspirin; Drug: Aspirin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Study Start Date: Sep 1, 2011
• Anticipated Primary Completion Date: Sep 1, 2013
• Anticipated Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin 100	Drug: Aspirin; single-dose aspirin in 100 mg 1 tablet every 24 hours
Active Comparator: Aspirin 200	Drug: Aspirin; single-dose aspirin 200 mg 1 tablet every 24 hours
Active Comparator: Aspirin 100 x 2	Drug: Aspirin; double-dose aspirin 100 mg 1 tablet every 12 hours

Outcome Measures

Primary Outcome Measures

1. change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin [one year]

2. change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin [one year]

Secondary Outcome Measures

1. change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin [one year]

2. change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin [one year]

3. change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin [one year]

4. change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Cardiologico Monzino, IRCCS	Milano		Italy	20138

Sponsors and Collaborators

• Centro Cardiologico Monzino
• Catholic University, Italy
• University of Chieti

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alessandro Parolari, Assistant Professor of Cardiac Surgery, Centro Cardiologico Monzino
• ClinicalTrials.gov Identifier: NCT01466452
• Other Study ID Numbers: S181/211
• First Posted: Nov 8, 2011
• Last Update Posted: Nov 8, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Aspirin

Study Results

No Results Posted as of Nov 8, 2011