Personalization of Long-Term Antiplatelet Therapy (RAPID EXTEND 2)
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|ClinicalTrials.gov Identifier: NCT03729401|
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles.
This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Infarction||Drug: Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily Drug: Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily Drug: Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily||Phase 4|
The present study is a pilot/vanguard 3-arm study that seeks to compare 3 possible strategies for patients that are 1 year post MI and PCI. The 3 randomized groups include: i) aspirin and ticagrelor 60 mg twice daily, ii) monotherapy with ticagrelor 60 mg twice daily and iii) a personalized arm (PA), where patients will get selective therapy based on demographic and genetic risks.
The PA group will use a modified DAPT score based on patient demographics to decide whether P2Y12 treatment is warranted. For those patients where treatment is warranted, a bedside genetic test will be used to determine whether they are carriers of at-risk genotypes, which put them at risk for under-responsiveness to clopidogrel (one of the specific P2Y12 inhibitors). Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.
The study will act as a vanguard study to prove feasibility of enrollment and document overall bleeding rates. The long-term goal of the study is determine whether a personalized approach will decrease bleeding versus an approach of DAPT with ticagrelor and versus an approach with ticagrelor monotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND 2 Randomized Study|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
Active Comparator: DAPT - Aspirin and Ticagrelor
As per results of the PEGASUS trial, patients will be treated with aspirin 81mg daily and ticagrelor 60mg twice daily
Drug: Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily
DAPT with aspirin and ticagrelor
Other Name: ASA, Brilinta
Experimental: Ticagrelor Monotherapy
Patients will only receive ticagrelor 60mg twice daily.
Drug: Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily
Other Name: Brilinta
Experimental: Personalized Therapy Arm
Patients allocated to the personalized arm (PA) will have a DAPT score calculated. For those with a score of < 2, only aspirin at 81 mg daily will be prescribed. For those with a score of ≥ 2, P2Y12 inhibitor choice will be dependent on carrier status of CYP2C19 LOF alleles. Heterozygous or homozygous carriers will receive be prescribed ticagrelor 60mg twice daily and non-carriers with will be prescribed clopidogrel 75mg daily.
Drug: Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily
Personalized therapy based on risk score and genotyping
Other Name: ASA, Brilinta, Plavix
- Bleeding Academic Research Consortium (BARC) Bleeding [ Time Frame: 2 years post randomization ]BARC bleeding types 2,3 or 5
- Feasibility for Patient Enrollment and Follow-up - measured by number of patients enrolled and followed over 2 years [ Time Frame: 2 years ]Number of participants enrolled and followed: Target of 260 patients over 2 years with over 90% follow-up (Vanguard Study target)
- Thrombolysis in Myocardial Infarction (TIMI) bleeding [ Time Frame: 1-3 years post randomization ]Incidence of TIMI bleeding - major and minor
- Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding [ Time Frame: 1-3 years post randomization ]Incidence of GUSTO bleeding - severe, moderate, mild
- All Cause Mortality [ Time Frame: 1 - 3 years post randomization ]Death due to any cause
- Cardiovascular Mortality [ Time Frame: 1 -3 years post randomization ]Death due to cardiovascular cause
- Myocardial Infarction [ Time Frame: 1 -3 years post randomization ]Myocardial infarction as defined by the 3rd universal definition on infarction
- Stroke [ Time Frame: 1-3 years ]Strokes defined as focal neurological deficit of >24 hrs and confirmed by imaging
- Stent Thrombosis [ Time Frame: 1 - 3 years post randomization ]Probable and definite stent thrombosis per ARC definition
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): NCT03729401
|Contact: Poppy MacPhee, BScN||6136967000 ext email@example.com|
|Principal Investigator:||Derek YF So, MD FRCPC||Ottawa Heart Institute Research Corporation|