Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor

Coronary Artery Disease Clinical Trial

— CABG-TIME  

Official title:

Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627521
• Other study ID #: REB#13-287
• Status: Recruiting
• Phase: Phase 4
• First received: December 3, 2015
• Last updated: February 15, 2017
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2017
• Source: St. Michael's Hospital, Toronto
• Contact: Asim Cheema, MD
• Phone: 4168645739
• Email: cheemaa[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at an early time point includes non ST elevation myocardial (NSTEMI) patients and those undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be unnecessary due to the significant inter individual variability in response to Ticagrelor. There is limited data to determine the optimum timing of CABG surgery in ACS patients treated with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients treated with a loading and/or maintenance dose of Ticagrelor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Accepted for CABG surgery

• Treatment with Ticagrelor within 48 hours

Exclusion Criteria:

• Anticoagulation therapy

• Prior CABG.

• Active bleeding or at high risk of bleeding

• Severe liver or renal disease.

• Hypersensitivity to ticagrelor

• History of intracranial hemorrhage

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• PRU guided CABG
Coronary Artery Bypass Surgery
• CABG per standard of care
Coronary Artery Bypass Surgery

Device:
• VerifyNow assay
Platelet reactivity Units by VerifyNow assay

Drug:
• Ticagrelor
Ticagrelor administration prior to randomization

Locations

Country	Name	City	State
Canada	St. Michael's hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups	up to 30 day