NCT03049085

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

February 2, 2017

Last Update Submit

February 7, 2017

Conditions

Coronary Artery DiseaseAspirin

Keywords

OPCABASAAspirin

Outcome Measures

Primary Outcomes (17)

  • 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 Outcomes (3)

  • Postoperative drainage (ml)

    12 hours and 24 hours following OPCAB

  • Bleeding complication

    < 30 days following OPCAB

  • Blood transfusions (units)

    < 30 days following OPCAB

Study Arms (2)

Aspirin group

ACTIVE COMPARATOR

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

Drug: Aspirin

Placebo group

PLACEBO COMPARATOR

75 mg Vit. C is administered 2 hours prior OPCAB

Drug: vitamin C

Interventions

AspirinDRUG

preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB

Also known as: Acetylsalicylic acid
Aspirin group
vitamin CDRUG

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

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
  • Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medinet Heart Centre

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinAscorbic Acid

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 9, 2017

Study Start

February 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

PL(1)