Efficacy and Safety of Aspirin Therapy With CABG

NCT ID: NCT02942680

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.

The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

acetylsalicylic acid started for 24 hours before surgery and determination of platelet function

Group Type EXPERIMENTAL

acetylsalicylic acid started for 24 hours before surgery

Intervention Type DRUG

Control

acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function

Group Type OTHER

acetylsalicylic acid stayed for 5 days before surgery

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acetylsalicylic acid started for 24 hours before surgery

Intervention Type DRUG

acetylsalicylic acid stayed for 5 days before surgery

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients 18 years of age or older
* Patient able to give informed consent

Exclusion Criteria

* Missing consent
* Urgent or emergent surgery
* Off-pump CABG
* Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
* History of bleeding diathesis, significant GI bleed, ICH, or liver failure
* Allergy to or intolerance of aspirin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander M. Chernyavskiy, MD PhD

Role: STUDY_CHAIR

Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meshalkin State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aleksey Kurguzov

Role: CONTACT

+9137011917

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aleksey kurguzov

Role: primary

+79137011917

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1184

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rivaroxaban Post Coronary Bypass Surgery
NCT06019741 COMPLETED PHASE4
Neuroaxial Prophylaxis for CABG
NCT04244435 UNKNOWN EARLY_PHASE1
Efficacy and Safety of Sodium Heparin
NCT00894985 COMPLETED PHASE3