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

NCT ID: NCT03049085

Last Updated: 2017-02-09

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease Aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin group

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB

Placebo group

75 mg Vit. C is administered 2 hours prior OPCAB

Group Type PLACEBO_COMPARATOR

vitamin C

Intervention Type DRUG

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

Interventions

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Aspirin

preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB

Intervention Type DRUG

vitamin C

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

Intervention Type DRUG

Other Intervention Names

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Acetylsalicylic acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medinet Heart Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medinet Heart Centre

Nowa Sól, Lubusz Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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Preoperative aspirin-OPCAB

Identifier Type: -

Identifier Source: org_study_id

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