Myocardial InjuryPhase 4INTREPIDNCT02291419
Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
A Phase 4 study testing ticagrelor and aspirin in people with Myocardial Injury, run by The Cleveland Clinic at 24 sites in United States.
Trial summary
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- ticagrelor and aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2015to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent before any study related procedures are performed.
- A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
- Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
- Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
- Undergone non-cardiac surgery requiring an overnight hospital stay.
- Women of childbearing potential who are sexually active must have a negative pregnancy test at enrollment and agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug.
- Able to be randomized within 35 days following the index surgery.
Who cannot join
- Post-operative ST-elevation Myocardial Infarction (STEMI).
- Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:
- active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)
- ongoing hemodynamic instability thought to be ischemia mediated or
- persistent anginal symptoms.
- Planned or urgent coronary angiography/revascularization.
Show all 20Show fewer
- A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
- History of intracranial hemorrhage
- Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.
- Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.
- Renal dialysis.
- Hepatic impairment with transaminase ≥3x ULN at time of randomization.
- Known contra-indication for use of ticagrelor.
- Estimated life expectancy of <1 year.
- Enrolled in another ongoing drug or device research protocol
- A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.
- A documented hypersensitivity to aspirin.
- Hypersensitivity to ticagrelor or any component of the product.
- Neurological or ophthalmic surgery during the index hospitalization.
- Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
McLaren Bay Region
Bay City, Michigan, 48708
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
VA Medical Center - Cleveland Louis Stokes
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
VA North Texas Health Care System
Dallas, Texas, 75216
Miami Valley Hospital
Dayton, Ohio, 45409
Henry Ford Hospital
Detroit, Michigan, 48202
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Saint Vincent Medical Group
Indianapolis, Indiana, 46260
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, 32209
University of Kentucky
Lexington, Kentucky, 40536
Arkansas Site Management Service, LLC
Little Rock, Arkansas, 72211
Central Georgia Heart Center
Macon, Georgia, 31201
University of Minnesota
Minneapolis, Minnesota, 55455
University of South Alabama Health System
Mobile, Alabama, 36617
McLaren Macomb
Mount Clemens, Michigan, 48043
New York University School of Medicine
New York, New York, 10016
Florida Hospital Orthopaedic Institute and Fracture Care Center
Orlando, Florida, 32804
Oregon Health and Science University
Portland, Oregon, 97239
University of South Florida
Tampa, Florida, 33060
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
About this study
Official title: An Open Label, Randomized Study to Determine the Rate of Cardiovascular Events at 1 yr for Patients With Elevated Troponins Post Major Non-cardiac Surgery and the Impact of Ticagrelor vs Aspirin on the Occurrence of Cardiovascular Events
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients.
Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome. This study will assess if the increased risk of these patients is modifiable by an anti-platelet medication and evaluate the safety of this medication.
Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months, with the last contact at one month post treatment discontinuation.
Read the detailed description
The objective of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels post major, non-cardiac surgery and to evaluate the efficacy and safety of ticagrelor treatment compared to aspirin in these patients.
Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome (ACS) and it is not certain if this is a modifiable disease process. Ticagrelor is a direct, reversible inhibitor of the platelet P2Y12ADP-receptor. It has been shown to be superior to clopidogrel in the setting of ACS. The clinical benefit of treating patients with port-operative troponin elevation with antiplatelet agents remains unexplored. The short half-life of ticagrelor makes it favorable to use in this setting.
This is an open label, randomized, parallel group study comparing ticagrelor to aspirin in patients who experience troponin elevations post major non-cardiac surgery. Patients will be randomized in an open-label fashion to receive either ticagrelor 90 mg twice daily or aspirin 81 mg once daily. Patients will be followed for 13 months post randomization (12 months of treatment and a phone call 30 days after study drug discontinuation). The maximum duration of treatment will be 12 months.
Follow-up visits will occur at Month 1, Month 6, and Month 12. Phone calls will be made at Month 3, Month 9, and at 30 days after study drug discontinuation.
Up to 1000 patients with post-operative troponin elevation ≥2x ULN within first 7 postoperative days, will be enrolled in the study.
- Conditions
- Myocardial Injury
- Being tested
- ticagrelor, aspirin
- Keywords
- ticagrelor, non-cardiac surgery, elevated troponin, myocardial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilinta
ticagrelor 90 mg bid
aspirinDrug
Also called Bayer, ASA
aspirin 81 mg daily
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor | Experimental | ticagrelor 90mg bid Receives: Drug: ticagrelor |
| aspirin | Active comparator | Patients in the aspirin arm will receive aspirin 81 mg daily orally Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.
Measured: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Secondary outcomes (4)
Cardiovascular Death
Time to first occurence of Cardiovascular death. The number of patients with events was reported.
Measured: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Myocardial Infarction or Coronary Revascularization
Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.
Measured: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
All-cause Death
Time to first occurence of All-cause death. The number of participants with events was reported.
Measured: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Stroke
Time to first occurence of Non-fatal stroke. The number of participants with events was reported.
Measured: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Enrollment expectations were not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Venu Menon, The Cleveland Clinic
- Investigators
- Venu Menon, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291419
- Sponsor's protocol ID
- CCAZ-2014
- Acronym
- INTREPID
- Status last verified
- Feb 2017
- First submitted
- 5 Nov 2014
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PubMed 19717846Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.
PubMed 22706835POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
PubMed 18479744Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
PubMed 26366956
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Study to Determine the Rate of Cardiovascular Events at 1 yr for Patients With Elevated Troponins Post Major Non-cardiac Surgery and the Impact of Ticagrelor vs Aspirin on the Occurrence of Cardiovascular Events
- ClinicalTrials.gov ID
- NCT02291419
- Acronym / sponsor ID
- INTREPID / CCAZ-2014
- Conditions
- Myocardial Injury
- Keywords
- ticagrelor, non-cardiac surgery, elevated troponin, myocardial injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment expectations were not met
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 9 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients.
Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome. This study will assess if the increased risk of these patients is modifiable by an anti-platelet medication and evaluate the safety of this medication.
Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months, with the last contact at one month post treatment discontinuation.
Detailed description
The objective of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels post major, non-cardiac surgery and to evaluate the efficacy and safety of ticagrelor treatment compared to aspirin in these patients.
Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome (ACS) and it is not certain if this is a modifiable disease process. Ticagrelor is a direct, reversible inhibitor of the platelet P2Y12ADP-receptor. It has been shown to be superior to clopidogrel in the setting of ACS. The clinical benefit of treating patients with port-operative troponin elevation with antiplatelet agents remains unexplored. The short half-life of ticagrelor makes it favorable to use in this setting.
This is an open label, randomized, parallel group study comparing ticagrelor to aspirin in patients who experience troponin elevations post major non-cardiac surgery. Patients will be randomized in an open-label fashion to receive either ticagrelor 90 mg twice daily or aspirin 81 mg once daily. Patients will be followed for 13 months post randomization (12 months of treatment and a phone call 30 days after study drug discontinuation). The maximum duration of treatment will be 12 months.
Follow-up visits will occur at Month 1, Month 6, and Month 12. Phone calls will be made at Month 3, Month 9, and at 30 days after study drug discontinuation.
Up to 1000 patients with post-operative troponin elevation ≥2x ULN within first 7 postoperative days, will be enrolled in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor | Experimental | Drug: ticagrelorticagrelor 90mg bid |
| aspirin | Active comparator | Drug: aspirinPatients in the aspirin arm will receive aspirin 81 mg daily orally |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent before any study related procedures are performed.
- A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
- Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
- Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
- Undergone non-cardiac surgery requiring an overnight hospital stay.
Key exclusion criteria (20 listed)
- Post-operative ST-elevation Myocardial Infarction (STEMI).
- Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:
- Planned or urgent coronary angiography/revascularization.
- A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
- History of intracranial hemorrhage
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 |
|---|---|---|
| ticagrelorAlso: Brilintaticagrelor 90 mg bid | Drug | ticagrelor |
| aspirinAlso: Bayer, ASAaspirin 81 mg daily | Drug | aspirin |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.
4 secondary outcomes
Cardiovascular Death
Time frame: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Myocardial Infarction or Coronary Revascularization
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
All-cause Death
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Stroke
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19717846Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Background: PubMed 22706835Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.
- Background: PubMed 18479744POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
- Derived from this study: PubMed 26366956Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
- Individual participant dataSharing planned: No
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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.
Venu Menon, MD principal investigator
The Cleveland Clinic
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor and aspirin in people with Myocardial Injury, run by The Cleveland Clinic at 24 sites in United States.
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 7 inclusion and 20 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: stopped early, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Adverse Cardiovascular Events (time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.). 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 NCT02291419, which also lists 4 linked publications.
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 9 Feb 2017.