Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor

Acute Coronary Syndrome Clinical Trial

— RAPID CABG  

Official title:

Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Complications - The RAPID-TITRATE CABG Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668562
• Other study ID #: 20150656
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 9, 2022

Study information

• Verified date: October 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 9, 2022
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made

Exclusion Criteria:

Patients are excluded if they:

• refuse consent for enrollment

• are deemed to require immediate CABG (Day 0 or day 1)

• have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI

• are undergoing concurrent valve surgery

• are intolerant or allergic to aspirin

• have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)

• received adjuvant therapy with a glycoprotein IIbIIIa inhibitor

• have a co-morbidity with life-expectancy of < 1 year

• have active bleeding

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Procedure:
• Early CABG (Day 2-3 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation
• Delayed CABG (Day 5-7 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe-massive bleeding	Class 3 or 4 UDPB (universal definition for peri-operative bleeding)	24 hours post CABG
Primary	12-hour chest tube drainage	Chest tube drainage in the first 12 hours after bypass surgery	12 hours post CABG
Secondary	Other major bleeding criteria (BARC)	Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding	48 hours post CABG
Secondary	Other major bleeding criteria (TIMI)	TIMI major/minor CABG bleeding	48 hours post CABG
Secondary	Other major bleeding criteria (CABG related life threatening bleed)	CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding	48 hours post CABG
Secondary	Transfusion (RBC)	Red Blood Cell (RBC) transfusion (in Units)	48 hours post CABG
Secondary	Transfusion (Platelet)	Platelet transfusion (in Units)	48 hours post CABG
Secondary	Peri-operative biomarker rise	CK, troponin rise post CABG	48 hours post CABG
Secondary	Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).	MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization	6 months and 1 year
Secondary	Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).	cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization	6 months and 1 year
Secondary	P2Y12 Reactivity Units (PRU) as a continuous variable	Platelet Function as Measured by VerifyNow P2Y12 assay	Baseline (at CABG), 24, 48, 72 hours post CABG
Secondary	ADP-induced Aggregation (AU) as a continuous variable	Platelet Function as Measured by Multiplate analyzer	Baseline (at CABG), 24, 48, 72 hours post CABG