Acute Coronary SyndromeRAPID CABGNCT02668562
Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor
A study testing Early CABG (Day 2-3 after ticagrelor discontinuation) and Delayed CABG (Day 5-7 after ticagrelor discontinuation) in people with Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Early CABG (Day 2-3 after ticagrelor discontinuation) and Delayed CABG (Day 5-7 after ticagrelor discontinuation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2016to 9 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T1C8
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
About this study
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
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Early CABG (Day 2-3 after ticagrelor discontinuation), Delayed CABG (Day 5-7 after ticagrelor discontinuation)
- Keywords
- acute coronary syndrome, coronary artery bypass surgery, ticagrelor, antiplatelet therapy, platelet function testing
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early CABG (Day 2-3 after ticagrelor discontinuation)Procedure or surgery
Timing for CABG after ticagrelor discontinuation
Delayed CABG (Day 5-7 after ticagrelor discontinuation)Procedure or surgery
Timing for CABG after ticagrelor discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Early CABG | Experimental | Patients to undergo early CABG Receives: Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation) |
| Delayed CABG | Active comparator | Patients to undergo delayed CABG Receives: Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe-massive bleeding
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
Measured: 24 hours post CABG
12-hour chest tube drainage
Chest tube drainage in the first 12 hours after bypass surgery
Measured: 12 hours post CABG
Secondary outcomes (10)
Other major bleeding criteria (BARC)
Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
Measured: 48 hours post CABG
Other major bleeding criteria (TIMI)
TIMI major/minor CABG bleeding
Measured: 48 hours post CABG
Other major bleeding criteria (CABG related life threatening bleed)
CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
Measured: 48 hours post CABG
Transfusion (RBC)
Red Blood Cell (RBC) transfusion (in Units)
Measured: 48 hours post CABG
Transfusion (Platelet)
Platelet transfusion (in Units)
Measured: 48 hours post CABG
Peri-operative biomarker rise
CK, troponin rise post CABG
Measured: 48 hours 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).
MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Measured: 6 months and 1 year
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
Measured: 6 months and 1 year
P2Y12 Reactivity Units (PRU) as a continuous variable
Platelet Function as Measured by VerifyNow P2Y12 assay
Measured: Baseline (at CABG), 24, 48, 72 hours post CABG
ADP-induced Aggregation (AU) as a continuous variable
Platelet Function as Measured by Multiplate analyzer
Measured: Baseline (at CABG), 24, 48, 72 hours post CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion9 Apr 2021
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Derek So, MD FRCPC FACC, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668562
- Sponsor's protocol ID
- 20150656
- Acronym
- RAPID CABG
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2016
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
So DYF, Wells GA, Lordkipanidze M, Chong AY, Ruel M, Perrault LP, Le May MR, Sun L, Tran D, Labinaz M, Glover C, Russo J, Welman M, Chan V, Chen L, Bernick J, Rubens F, Tanguay JF; RAPID CABG Investigators. Early vs Delayed Bypass Surgery in Patients With Acute Coronary Syndrome Receiving Ticagrelor: The RAPID CABG Randomized Open-Label Noninferiority Trial. JAMA Surg. 2025 Apr 1;160(4):387-394. doi: 10.1001/jamasurg.2024.7066.
PubMed 39969871
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02668562
- Acronym / sponsor ID
- RAPID CABG / 20150656
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, coronary artery bypass surgery, ticagrelor, antiplatelet therapy, platelet function testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2016 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early CABG | Experimental | Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)Patients to undergo early CABG |
| Delayed CABG | Active comparator | Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)Patients to undergo delayed CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early CABG (Day 2-3 after ticagrelor discontinuation)Timing for CABG after ticagrelor discontinuation | Procedure or surgery | Early CABG |
| Delayed CABG (Day 5-7 after ticagrelor discontinuation)Timing for CABG after ticagrelor discontinuation | Procedure or surgery | Delayed CABG |
Primary outcome
Severe-massive bleeding
Time frame: 24 hours post CABG
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
12-hour chest tube drainage
Time frame: 12 hours post CABG
Chest tube drainage in the first 12 hours after bypass surgery
10 secondary outcomes
Other major bleeding criteria (BARC)
Time frame: 48 hours post CABG
Other major bleeding criteria (TIMI)
Time frame: 48 hours post CABG
Other major bleeding criteria (CABG related life threatening bleed)
Time frame: 48 hours post CABG
Transfusion (RBC)
Time frame: 48 hours post CABG
Transfusion (Platelet)
Time frame: 48 hours post CABG
Peri-operative biomarker rise
Time frame: 48 hours 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
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
P2Y12 Reactivity Units (PRU) as a continuous variable
Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG
ADP-induced Aggregation (AU) as a continuous variable
Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 39969871So DYF, Wells GA, Lordkipanidze M, Chong AY, Ruel M, Perrault LP, Le May MR, Sun L, Tran D, Labinaz M, Glover C, Russo J, Welman M, Chan V, Chen L, Bernick J, Rubens F, Tanguay JF; RAPID CABG Investigators. Early vs Delayed Bypass Surgery in Patients With Acute Coronary Syndrome Receiving Ticagrelor: The RAPID CABG Randomized Open-Label Noninferiority Trial. JAMA Surg. 2025 Apr 1;160(4):387-394. doi: 10.1001/jamasurg.2024.7066.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek So, MD FRCPC FACC principal investigator
Ottawa Heart Institute Research Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early CABG (Day 2-3 after ticagrelor discontinuation) and Delayed CABG (Day 5-7 after ticagrelor discontinuation) in people with Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe-massive bleeding (time frame: 24 hours post CABG). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.