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Coronary Artery DiseasePhase 4RAPID EXTENDNCT03729401

Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND

A Phase 4 study testing Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily, Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily and Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily in people with Coronary Artery Disease and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily, Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily and Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteCanada
Study dates
22 Aug 2019to 26 Feb 2026
Phase
Phase 4
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >50 years old at 1-year after myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)) during which they had percutaneous coronary intervention (PCI)
  • Compliant with dual antiplatelet therapy (DAPT) for ≥ 1 year without an ischemic or bleeding complication after PCI
  • Still on DAPT regimen at enrollment
  • Patients must have 1 of the following atherothrombotic risk enrichment criteria:
  • Age≥ 65 years ii) Diabetes iii) 2nd Prior MI (>1 year ago) iv) multi-vessel coronary disease v) creatinine clearance (CrCl) <60 mL/min.

Who cannot join

  • Intolerance to ticagrelor or clopidogrel
  • >18 months post percutaneous coronary intervention (PCI) and myocardial infarction (MI)
  • Requirement of a P2Y12 inhibitor
  • Requirement of oral anticoagulation
  • Take concurrent CYP3A inducing drugs which may interact with ticagrelor (e.g. anti-epileptic drugs)
  • History of stroke, TIA or intracranial bleed
Show all 13Show fewer
  • Recent GI bleed or major surgery
  • Life expectancy of < 1 year
  • Platelet count < 100,000/μl
  • Bleeding diathesis
  • On dialysis
  • Severe liver disease
  • At risk for bradycardia.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

Other trials in Canada

About this study

Official title: Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND Randomized Study

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.

Read the detailed description

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.

Being tested
Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily, Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily, Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily
Keywords
1-year post myocardial infarction, P2Y12 inhibitor, antiplatelet regimen
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice dailyDrug

    Also called ASA, Brilinta

    DAPT with aspirin and ticagrelor

  • Ticagrelor Monotherapy: Ticagrelor 60 mg twice dailyDrug

    Also called Brilinta

    Ticagrelor monotherapy

  • Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once dailyDrug

    Also called ASA, Brilinta, Plavix

    Personalized therapy based on risk score and genotyping

Study groups in NCT03729401
Study groupRoleWhat they receive
DAPT - Aspirin and TicagrelorActive comparatorAs per results of the PEGASUS trial, patients will be treated with aspirin 81mg daily and ticagrelor 60mg twice daily
Receives: Drug: Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily
Ticagrelor MonotherapyExperimentalPatients will only receive ticagrelor 60mg twice daily.
Receives: Drug: Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily
Personalized Therapy ArmExperimentalPatients 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.
Receives: Drug: Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding Academic Research Consortium (BARC) Bleeding

    BARC bleeding types 2,3 or 5

    Measured: 2 years post randomization

  2. Feasibility for Patient Enrollment and Follow-up - measured by number of patients enrolled and followed over 2 years

    Number of participants enrolled and followed: Target of 260 patients over 2 years with over 90% follow-up (Vanguard Study target)

    Measured: 2 years

Secondary outcomes (7)

  1. Thrombolysis in Myocardial Infarction (TIMI) bleeding

    Incidence of TIMI bleeding - major and minor

    Measured: 1-3 years post randomization

  2. Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding

    Incidence of GUSTO bleeding - severe, moderate, mild

    Measured: 1-3 years post randomization

  3. All Cause Mortality

    Death due to any cause

    Measured: 1 - 3 years post randomization

  4. Cardiovascular Mortality

    Death due to cardiovascular cause

    Measured: 1 -3 years post randomization

  5. Myocardial Infarction

    Myocardial infarction as defined by the 3rd universal definition on infarction

    Measured: 1 -3 years post randomization

  6. Stroke

    Strokes defined as focal neurological deficit of >24 hrs and confirmed by imaging

    Measured: 1-3 years

  7. Stent Thrombosis

    Probable and definite stent thrombosis per ARC definition

    Measured: 1 - 3 years post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start22 Aug 2019
  3. Primary completion31 Mar 2024
  4. Study completion26 Feb 2026

Why it stopped: Testing supplies unavailable.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729401
Sponsor's protocol ID
20180593
Acronym
RAPID EXTEND
Status last verified
Dec 2024
First submitted
15 Oct 2018
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.

    PubMed 25773268

  • Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775.

    PubMed 27022822

  • Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.

    PubMed 27026020

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily, Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily and Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily in people with Coronary Artery Disease and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site 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 5 inclusion and 13 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

The study was stopped early (reason given: Testing supplies unavailable.). Results are not available in the source record.

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?

Bleeding Academic Research Consortium (BARC) Bleeding (time frame: 2 years post randomization). 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 NCT03729401, which also lists 3 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 6 May 2026.

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