Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial
Background: Type 2 myocardial infarction (T2MI) occurs when myocardial oxygen demand exceeds myocardial oxygen supply. T2MIs occur more frequently and have worse outcomes compared to Type 1 myocardial infarction caused by an acute plaque rupture. No clinical trial evidence is available to guide phar...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423000893 |
| _version_ | 1797799939374317568 |
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| author | Pishoy Gouda Robert Kay Arjun Gupta Tiffany Yuen Malik Elharram Jean-Bernard Breau Syed Gilani Darren Lau Janek Senaratne Albert KY. Tsui Ross Tsuyuki Michelle Graham |
| author_facet | Pishoy Gouda Robert Kay Arjun Gupta Tiffany Yuen Malik Elharram Jean-Bernard Breau Syed Gilani Darren Lau Janek Senaratne Albert KY. Tsui Ross Tsuyuki Michelle Graham |
| author_sort | Pishoy Gouda |
| collection | DOAJ |
| description | Background: Type 2 myocardial infarction (T2MI) occurs when myocardial oxygen demand exceeds myocardial oxygen supply. T2MIs occur more frequently and have worse outcomes compared to Type 1 myocardial infarction caused by an acute plaque rupture. No clinical trial evidence is available to guide pharmacological therapies in this high-risk population. Methods: The Rivaroxaban in Type 2 Myocardial Infarction (R2MI) trial (NCT04838808) was a trainee-led, pragmatic, pilot study that randomised patients with a T2MI to either rivaroxaban 2.5 mg twice daily or placebo. The trial was stopped early due to low recruitment. Investigators explored the challenges of conducting the trial in this population. This was supplemented by a retrospective chart review of 10,000 consecutive troponin assays undertaken during the study period. Results: Over a 1-year period, 276 patients with T2MI were screened for inclusion of which only 7 (2.5%) were randomised in the trial. Study investigators identified trial design and participant population factors that limited recruitment. These included: heterogeneity of patient presentation, poor clinical prognosis, and lack of dedicated non-trainee study personnel. The major limitation to recruitment was the frequency of identified exclusion criterion. The retrospective chart review identified 1715 patients with an elevated high-sensitivity troponin level, of which 916 (53%) were adjudicated to be related to T2MI. Of these, 94.5% possessed an exclusion criterion for the trial. Conclusion: Patients with a T2MI are challenging to recruit into clinical trials involving oral anticoagulation. Future studies should account for only ∼1 in every 20 screened individuals being a candidate for study recruitment. |
| first_indexed | 2024-03-13T04:26:40Z |
| format | Article |
| id | doaj.art-30481d62b24e4a3ea7ad746db2e28cdf |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-13T04:26:40Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-30481d62b24e4a3ea7ad746db2e28cdf2023-06-20T04:20:22ZengElsevierContemporary Clinical Trials Communications2451-86542023-06-0133101143Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trialPishoy Gouda0Robert Kay1Arjun Gupta2Tiffany Yuen3Malik Elharram4Jean-Bernard Breau5Syed Gilani6Darren Lau7Janek Senaratne8Albert KY. Tsui9Ross Tsuyuki10Michelle Graham11University of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Division of Internal Medicine, CanadaUniversity of Alberta, Division of Cardiology, CanadaUniversity of Alberta, Department of Laboratory Medicine and Pathology, Canada; University of Alberta, Faculty of Medicine and Dentistry, College of Health Sciences, CanadaUniversity of Alberta, Division of Cardiology, Canada; University of Alberta, Department of Pharmacology, Faculty of Medicine and Dentistry, CanadaUniversity of Alberta, Division of Cardiology, Canada; Corresponding author. 2C2, WMC, 8440-112 Street Edmonton, Alberta, T6G 2G7, Canada.Background: Type 2 myocardial infarction (T2MI) occurs when myocardial oxygen demand exceeds myocardial oxygen supply. T2MIs occur more frequently and have worse outcomes compared to Type 1 myocardial infarction caused by an acute plaque rupture. No clinical trial evidence is available to guide pharmacological therapies in this high-risk population. Methods: The Rivaroxaban in Type 2 Myocardial Infarction (R2MI) trial (NCT04838808) was a trainee-led, pragmatic, pilot study that randomised patients with a T2MI to either rivaroxaban 2.5 mg twice daily or placebo. The trial was stopped early due to low recruitment. Investigators explored the challenges of conducting the trial in this population. This was supplemented by a retrospective chart review of 10,000 consecutive troponin assays undertaken during the study period. Results: Over a 1-year period, 276 patients with T2MI were screened for inclusion of which only 7 (2.5%) were randomised in the trial. Study investigators identified trial design and participant population factors that limited recruitment. These included: heterogeneity of patient presentation, poor clinical prognosis, and lack of dedicated non-trainee study personnel. The major limitation to recruitment was the frequency of identified exclusion criterion. The retrospective chart review identified 1715 patients with an elevated high-sensitivity troponin level, of which 916 (53%) were adjudicated to be related to T2MI. Of these, 94.5% possessed an exclusion criterion for the trial. Conclusion: Patients with a T2MI are challenging to recruit into clinical trials involving oral anticoagulation. Future studies should account for only ∼1 in every 20 screened individuals being a candidate for study recruitment.http://www.sciencedirect.com/science/article/pii/S2451865423000893Type 2 myocardial infarctionAnticoagulationClinical trials |
| spellingShingle | Pishoy Gouda Robert Kay Arjun Gupta Tiffany Yuen Malik Elharram Jean-Bernard Breau Syed Gilani Darren Lau Janek Senaratne Albert KY. Tsui Ross Tsuyuki Michelle Graham Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial Contemporary Clinical Trials Communications Type 2 myocardial infarction Anticoagulation Clinical trials |
| title | Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| title_full | Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| title_fullStr | Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| title_full_unstemmed | Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| title_short | Anticoagulation in type 2 myocardial infarctions: Lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| title_sort | anticoagulation in type 2 myocardial infarctions lessons learned from the rivaroxaban in type 2 myocardial infarctions feasibility trial |
| topic | Type 2 myocardial infarction Anticoagulation Clinical trials |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423000893 |
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