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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Arteriosclerosis
• Intervention / Treatment: Drug: Aspirin; Drug: Aspirin; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alessandro Parolari, MD PhD; Phone Number: 2355 +39 025800; Email: alessandro.parolari@ccfm.it

Study Locations

• Italy
  • Milano, Italy, 20138
    • Recruiting
    • Centro Cardiologico Monzino, IRCCS
    • Contact: Alessandro Parolari, MD PhD; Phone Number: 2355 +39 02 5800; Email: alessandro.parolari@ccfm.it
    • Principal Investigator: Alessandro Parolari, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin 100	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
Active Comparator: Aspirin 200	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
Active Comparator: Aspirin 100 x 2	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin	one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin	one year
change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin	one year
change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin	one year
change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin	one year

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Catholic University, Italy; University of Chieti

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: S181/211