NCT02030548

Brief Summary

The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

January 7, 2014

Last Update Submit

June 5, 2019

Conditions

Acute Coronary Syndrome

Keywords

CABGdual antiplatelet therapyaspirinclopidogrelprasugrelticagrelor

Outcome Measures

Primary Outcomes (1)

  • calculated blood loss

    until postoperative day 5

Secondary Outcomes (1)

  • mortality

    from index surgery until one year after index surgery

Study Arms (1)

acute CABG

patients undergoing acute CABG with or without valve replacement during dual antiplatelet therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients undergoing acute CABG with or without valve during dual antiplatelet therapy

You may qualify if:

  • consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy

You may not qualify if:

  • concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anesthesiology and Intensive Care Medicine

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Elisabeth Mahla, MD

    Dept. of Anesthesiology and Intensive Care Medicine, MUG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

AU(1)