NCT02209909

Brief Summary

Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 21, 2016

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

July 31, 2014

Last Update Submit

April 20, 2016

Conditions

Coronary Artery Disease

Keywords

preoperative aspirin useplatelet activationoff pump coronary artery bypass

Outcome Measures

Primary Outcomes (1)

  • change from baseline in platelet p-selectin at 48 hours after operation

    Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.

    after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Secondary Outcomes (1)

  • change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation

    after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Other Outcomes (1)

  • change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operation

    after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Study Arms (2)

aspirin continuation

EXPERIMENTAL

Intervention : Low-dose aspirin (\< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.

Drug: aspirin continuation

aspirin discontinuation

EXPERIMENTAL

Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.

Drug: aspirin discontinuation

Interventions

aspirin continuationDRUG

Patients are randomized to continue aspirin before OPCAB surgery.

Also known as: Low-dose aspirin (< 100mg/day)
aspirin continuation
aspirin discontinuationDRUG

Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.

aspirin discontinuation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age : 20-80
  • elective OPCAB
  • informed consent

You may not qualify if:

  • coagulation disorder
  • emergency operation, re-operation
  • co-existing valvular disease
  • less than 6 months after cerebral vascular accident
  • heparin induced thrombocytopenia
  • heparin resistance
  • menstrual phase
  • preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
  • less than 12 months after myocardiac infarction
  • less than 10 days after unstable angina
  • less than 30 days after percutaneous coronary intervention
  • less than 6 wks after bare metal stent insertion
  • less than 12 months after drug eluting stent insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yunseok Jeon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 6, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 21, 2016

Record last verified: 2014-08

Locations

KR(1)