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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Centro Cardiologico Monzino.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Catholic University, Italy
University of Chieti
Information provided by (Responsible Party):
Alessandro Parolari, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT01466452
First received: October 20, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Coronary Arteriosclerosis
Drug: Aspirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466452

Contacts
Contact: Alessandro Parolari, MD PhD +39 025800 ext 2355 alessandro.parolari@ccfm.it

Locations
Italy
Centro Cardiologico Monzino, IRCCS Recruiting
Milano, Italy, 20138
Contact: Alessandro Parolari, MD PhD    +39 02 5800 ext 2355    alessandro.parolari@ccfm.it   
Principal Investigator: Alessandro Parolari, MD PhD         
Sponsors and Collaborators
Centro Cardiologico Monzino
Catholic University, Italy
University of Chieti
  More Information

No publications provided

Responsible Party: Alessandro Parolari, Assistant Professor of Cardiac Surgery, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT01466452     History of Changes
Other Study ID Numbers: S181/211
Study First Received: October 20, 2011
Last Updated: November 7, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014