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

NCT01466452 | Unknown Phase 2

• 1 other identifier: S181/211
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (3)

Aspirin 100

ACTIVE COMPARATOR

Drug: Aspirin

Aspirin 200

ACTIVE COMPARATOR

Drug: Aspirin

Aspirin 100 x 2

ACTIVE COMPARATOR

Drug: Aspirin

Interventions

Aspirin DRUG

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

Aspirin 100

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Catholic University, Italy: collaborator
• University of Chieti: collaborator

Study Sites (1)

Centro Cardiologico Monzino, IRCCS

Milan, Milano, 20138, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Alessandro Parolari, MD PhD

CONTACT

+39 025800; alessandro.parolari@ccfm.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiac Surgery

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 8, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

IT (1)