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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Aspirin
• Intervention / Treatment: Drug: Aspirin; Drug: vitamin C

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	6 hours following OPCAB
Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	12 hours following OPCAB
Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	24 hours following OPCAB
Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	72 hours following OPCAB
Inflammation	Inflammation detected by CRP (mg/l)	6 hours following OPCAB
Inflammation	Inflammation detected by CRP (mg/l)	12 hours following OPCAB
Inflammation	Inflammation detected by CRP (mg/l)	24 hours following OPCAB
Inflammation	Inflammation detected by CRP (mg/l)	72 hours following OPCAB
Kidney Injury	Kidney injury detected by creatinine (mg/dl)	6 hours following OPCAB
Kidney Injury	Kidney injury detected by creatinine (mg/dl)	12 hours following OPCAB
Kidney Injury	Kidney injury detected by creatinine (mg/dl)	24 hours following OPCAB
Kidney Injury	Kidney injury detected by creatinine (mg/dl)	72 hours following OPCAB
All-cause mortality or MACE up to 30 days after surgery		30 days after surgery
Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	6 hours following OPCAB
Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	12 hours following OPCAB
Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	24 hours following OPCAB
Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	72 hours following OPCAB

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medinet Heart Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Aspirin; OPCAB; ASA
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protective Agents; Micronutrients; Vitamins; Antioxidants; Aspirin; Ascorbic Acid
• Other Study ID Numbers: Preoperative aspirin-OPCAB

Drug and device information, study documents

• 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