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

Sponsor
Medinet Heart Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT03049085
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
26.9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2017
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
May 1, 2019

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Myocardial Injury [6 hours following OPCAB]

      Myocardial injury detected by Troponin T (ng/ml)

    2. Myocardial Injury [12 hours following OPCAB]

      Myocardial injury detected by Troponin T (ng/ml)

    3. Myocardial Injury [24 hours following OPCAB]

      Myocardial injury detected by Troponin T (ng/ml)

    4. Myocardial Injury [72 hours following OPCAB]

      Myocardial injury detected by Troponin T (ng/ml)

    5. Inflammation [6 hours following OPCAB]

      Inflammation detected by CRP (mg/l)

    6. Inflammation [12 hours following OPCAB]

      Inflammation detected by CRP (mg/l)

    7. Inflammation [24 hours following OPCAB]

      Inflammation detected by CRP (mg/l)

    8. Inflammation [72 hours following OPCAB]

      Inflammation detected by CRP (mg/l)

    9. Kidney Injury [6 hours following OPCAB]

      Kidney injury detected by creatinine (mg/dl)

    10. Kidney Injury [12 hours following OPCAB]

      Kidney injury detected by creatinine (mg/dl)

    11. Kidney Injury [24 hours following OPCAB]

      Kidney injury detected by creatinine (mg/dl)

    12. Kidney Injury [72 hours following OPCAB]

      Kidney injury detected by creatinine (mg/dl)

    13. All-cause mortality or MACE up to 30 days after surgery [30 days after surgery]

    14. Myocardial Injury [6 hours following OPCAB]

      Myocardial injury detected by CK-MB (U/l)

    15. Myocardial Injury [12 hours following OPCAB]

      Myocardial injury detected by CK-MB (U/l)

    16. Myocardial Injury [24 hours following OPCAB]

      Myocardial injury detected by CK-MB (U/l)

    17. Myocardial Injury [72 hours following OPCAB]

      Myocardial injury detected by CK-MB (U/l)

    Secondary Outcome Measures

    1. Postoperative drainage (ml) [12 hours and 24 hours following OPCAB]

    2. Bleeding complication [< 30 days following OPCAB]

      reoperation for bleeding, cardiac tamponade

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medinet Heart Centre Nowa Sol Lubuskie Poland 67-100

    Sponsors and Collaborators

    • Medinet Heart Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medinet Heart Centre
    ClinicalTrials.gov Identifier:
    NCT03049085
    Other Study ID Numbers:
    • Preoperative aspirin-OPCAB
    First Posted:
    Feb 9, 2017
    Last Update Posted:
    Feb 9, 2017
    Last Verified:
    Feb 1, 2017
    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:
    Coronary Artery Disease
    Aspirin
    Ascorbic Acid

    Study Results

    No Results Posted as of Feb 9, 2017