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Status unknownNCT03049085Updated Feb 9, 2017

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

A Phase 4 interventional study of Aspirin and vitamin C in Coronary Artery Disease and Aspirin, sponsored by Medinet Heart Centre. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Medinet Heart Centre · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Artery Disease
  • Aspirin

Keywords

  • OPCAB
  • ASA
  • Aspirin
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 300 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medinet Heart Centre is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Aspirin group

    a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB

    Drug: Aspirin

  • Placebo comparator
    Placebo group

    75 mg Vit. C is administered 2 hours prior OPCAB

    Drug: vitamin C

Interventions

  • DrugAspirin

    preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB

    Also known as: Acetylsalicylic acid

  • Drugvitamin C

    preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB

06

What researchers measure

Primary outcomes

  1. Myocardial Injury

    Myocardial injury detected by Troponin T (ng/ml)

    Time frame: 6 hours following OPCAB

  2. Myocardial Injury

    Myocardial injury detected by Troponin T (ng/ml)

    Time frame: 12 hours following OPCAB

  3. Myocardial Injury

    Myocardial injury detected by Troponin T (ng/ml)

    Time frame: 24 hours following OPCAB

  4. Myocardial Injury

    Myocardial injury detected by Troponin T (ng/ml)

    Time frame: 72 hours following OPCAB

  5. Inflammation

    Inflammation detected by CRP (mg/l)

    Time frame: 6 hours following OPCAB

  6. Inflammation

    Inflammation detected by CRP (mg/l)

    Time frame: 12 hours following OPCAB

  7. Inflammation

    Inflammation detected by CRP (mg/l)

    Time frame: 24 hours following OPCAB

  8. Inflammation

    Inflammation detected by CRP (mg/l)

    Time frame: 72 hours following OPCAB

  9. Kidney Injury

    Kidney injury detected by creatinine (mg/dl)

    Time frame: 6 hours following OPCAB

  10. Kidney Injury

    Kidney injury detected by creatinine (mg/dl)

    Time frame: 12 hours following OPCAB

  11. Kidney Injury

    Kidney injury detected by creatinine (mg/dl)

    Time frame: 24 hours following OPCAB

  12. Kidney Injury

    Kidney injury detected by creatinine (mg/dl)

    Time frame: 72 hours following OPCAB

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

    Time frame: 30 days after surgery

  14. Myocardial Injury

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

    Time frame: 6 hours following OPCAB

  15. Myocardial Injury

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

    Time frame: 12 hours following OPCAB

  16. Myocardial Injury

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

    Time frame: 24 hours following OPCAB

  17. Myocardial Injury

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

    Time frame: 72 hours following OPCAB

Secondary outcomes

  1. Postoperative drainage (ml)

    Time frame: 12 hours and 24 hours following OPCAB

  2. Bleeding complication

    reoperation for bleeding, cardiac tamponade

    Time frame: < 30 days following OPCAB

  3. Blood transfusions (units)

    Time frame: < 30 days following OPCAB

07

Study locations

1 site
  • Medinet Heart Centre
    Nowa Sol, Lubuskie 67-100, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03049085
Lead sponsor
Medinet Heart Centre
Responsible party
Sponsor
First posted
Feb 9, 2017
Start date
Feb 1, 2017
Primary completion
May 2018 (estimated)
Completion
May 2019 (estimated)
Last update
Feb 9, 2017

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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