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

Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03049085

Enrollment

300

Registered

2017-02-09

Start date

2017-02-01

Completion date

2019-05-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin, Coronary Artery Disease

Keywords

OPCAB, ASA, Aspirin

Brief summary

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

Interventions

DRUGAspirin

preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB

DRUGvitamin C

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Myocardial Injury	6 hours following OPCAB	Myocardial injury detected by Troponin T (ng/ml)
Inflammation	6 hours following OPCAB	Inflammation detected by CRP (mg/l)
Kidney Injury	6 hours following OPCAB	Kidney injury detected by creatinine (mg/dl)
All-cause mortality or MACE up to 30 days after surgery	30 days after surgery	—

Secondary

Measure	Time frame	Description
Bleeding complication	< 30 days following OPCAB	reoperation for bleeding, cardiac tamponade
Blood transfusions (units)	< 30 days following OPCAB	—
Postoperative drainage (ml)	12 hours and 24 hours following OPCAB	—

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026