Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor (RAPID CABG)
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ClinicalTrials.gov Identifier: NCT02668562 |
Recruitment Status :
Completed
First Posted : January 29, 2016
Last Update Posted : April 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation) Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 143 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | April 9, 2021 |
Actual Study Completion Date : | March 9, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Early CABG
Patients to undergo early CABG
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Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation |
Active Comparator: Delayed CABG
Patients to undergo delayed CABG
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Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation |
- Severe-massive bleeding [ Time Frame: 24 hours post CABG ]Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
- Other major bleeding criteria (BARC) [ Time Frame: 48 hours post CABG ]Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
- Other major bleeding criteria (TIMI) [ Time Frame: 48 hours post CABG ]TIMI major/minor CABG bleeding
- Other major bleeding criteria (CABG related life threatening bleed) [ Time Frame: 48 hours post CABG ]CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
- Transfusion (RBC) [ Time Frame: 48 hours post CABG ]Red Blood Cell (RBC) transfusion (in Units)
- Transfusion (Platelet) [ Time Frame: 48 hours post CABG ]Platelet transfusion (in Units)
- Peri-operative biomarker rise [ Time Frame: 48 hours post CABG ]CK, troponin rise post CABG
- 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). [ Time Frame: 6 months and 1 year ]MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
- 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). [ Time Frame: 6 months and 1 year ]cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
- P2Y12 Reactivity Units (PRU) as a continuous variable [ Time Frame: Baseline (at CABG), 24, 48, 72 hours post CABG ]Platelet Function as Measured by VerifyNow P2Y12 assay
- ADP-induced Aggregation (AU) as a continuous variable [ Time Frame: Baseline (at CABG), 24, 48, 72 hours post CABG ]Platelet Function as Measured by Multiplate analyzer

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668562
Canada, Ontario | |
University of Ottawa Heart Institute | |
Ottawa, Ontario, Canada, K1Y4W7 | |
Canada, Quebec | |
Montreal Heart Institute | |
Montreal, Quebec, Canada, H1T1C8 |
Principal Investigator: | Derek So, MD FRCPC FACC | Ottawa Heart Institute Research Corporation |
Responsible Party: | Ottawa Heart Institute Research Corporation |
ClinicalTrials.gov Identifier: | NCT02668562 |
Other Study ID Numbers: |
20150656 |
First Posted: | January 29, 2016 Key Record Dates |
Last Update Posted: | April 26, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
acute coronary syndrome coronary artery bypass surgery ticagrelor antiplatelet therapy platelet function testing |
Acute Coronary Syndrome Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Ticagrelor |
Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |