Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049085
Recruitment Status : Unknown
Verified February 2017 by Medinet Heart Centre.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Medinet Heart Centre

Brief Summary:
Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Aspirin Drug: Aspirin Drug: vitamin C Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin group
a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB
Drug: Aspirin
preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB
Other Name: Acetylsalicylic acid

Placebo Comparator: Placebo group
75 mg Vit. C is administered 2 hours prior OPCAB
Drug: vitamin C
preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB




Primary Outcome Measures :
  1. Myocardial Injury [ Time Frame: 6 hours following OPCAB ]
    Myocardial injury detected by Troponin T (ng/ml)

  2. Myocardial Injury [ Time Frame: 12 hours following OPCAB ]
    Myocardial injury detected by Troponin T (ng/ml)

  3. Myocardial Injury [ Time Frame: 24 hours following OPCAB ]
    Myocardial injury detected by Troponin T (ng/ml)

  4. Myocardial Injury [ Time Frame: 72 hours following OPCAB ]
    Myocardial injury detected by Troponin T (ng/ml)

  5. Inflammation [ Time Frame: 6 hours following OPCAB ]
    Inflammation detected by CRP (mg/l)

  6. Inflammation [ Time Frame: 12 hours following OPCAB ]
    Inflammation detected by CRP (mg/l)

  7. Inflammation [ Time Frame: 24 hours following OPCAB ]
    Inflammation detected by CRP (mg/l)

  8. Inflammation [ Time Frame: 72 hours following OPCAB ]
    Inflammation detected by CRP (mg/l)

  9. Kidney Injury [ Time Frame: 6 hours following OPCAB ]
    Kidney injury detected by creatinine (mg/dl)

  10. Kidney Injury [ Time Frame: 12 hours following OPCAB ]
    Kidney injury detected by creatinine (mg/dl)

  11. Kidney Injury [ Time Frame: 24 hours following OPCAB ]
    Kidney injury detected by creatinine (mg/dl)

  12. Kidney Injury [ Time Frame: 72 hours following OPCAB ]
    Kidney injury detected by creatinine (mg/dl)

  13. All-cause mortality or MACE up to 30 days after surgery [ Time Frame: 30 days after surgery ]
  14. Myocardial Injury [ Time Frame: 6 hours following OPCAB ]
    Myocardial injury detected by CK-MB (U/l)

  15. Myocardial Injury [ Time Frame: 12 hours following OPCAB ]
    Myocardial injury detected by CK-MB (U/l)

  16. Myocardial Injury [ Time Frame: 24 hours following OPCAB ]
    Myocardial injury detected by CK-MB (U/l)

  17. Myocardial Injury [ Time Frame: 72 hours following OPCAB ]
    Myocardial injury detected by CK-MB (U/l)


Secondary Outcome Measures :
  1. Postoperative drainage (ml) [ Time Frame: 12 hours and 24 hours following OPCAB ]
  2. Bleeding complication [ Time Frame: < 30 days following OPCAB ]
    reoperation for bleeding, cardiac tamponade

  3. Blood transfusions (units) [ Time Frame: < 30 days following OPCAB ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
  • Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB

Exclusion Criteria:

  • Patients undergoing on-pump coronary artery bypass grafting
  • Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
  • Intraoperative conversion to on-pump coronary artery bypass grafting
  • Patients with inherited blood-clotting disorders
  • Patients undergoing other cardiac operations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049085


Locations
Layout table for location information
Poland
Medinet Heart Centre
Nowa Sol, Lubuskie, Poland, 67-100
Sponsors and Collaborators
Medinet Heart Centre

Layout table for additonal information
Responsible Party: Medinet Heart Centre
ClinicalTrials.gov Identifier: NCT03049085     History of Changes
Other Study ID Numbers: Preoperative aspirin-OPCAB
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medinet Heart Centre:
OPCAB
ASA
Aspirin
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics