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Stable Coronary SyndromePhase 4NCT03224923

A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)

A Phase 4 study testing Ticagrelor 60mg, Clopidogrel 75mg and Aspirin 81 mg in people with Stable Coronary Syndrome and Percutaneous Coronary Intervention, 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 with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ticagrelor 60mg, Clopidogrel 75mg and Aspirin 81 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteCanada
Study dates
18 Aug 2017to 30 Sep 2018
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

  • non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) at presentation for index PCI who have successfully completed >1-year follow-up of RAPID MANAGE or TAILOR-PCI trials without having incurred an ischemic or bleeding outcome while on DAPT
  • Patients with DAPT interruption after 1 year will be eligible, if within 3 years of index MI
  • Patients must also have 1 of the following atherothrombotic risk enrichment criteria:
  • age ≥ 65 years
  • diabetes
  • 2nd prior MI (> 1 year ago)
  • multi-vessel coronary disease
  • Creatinine Clearance < 60mL/min

Who cannot join

  • Patients will be excluded from the study if they:
  • refuse consent
  • are > 3 years post MI
  • are deemed to require a P2Y12 inhibitor
  • require oral anticoagulation
  • have a history of stroke, transient ischemic attack (TIA) or intracranial bleed
Show all 13Show fewer
  • have had a recent GI bleed or major surgery
  • have a life expectancy of < 1 year
  • have a platelet count < 100,000/μl
  • have a bleeding diathesis
  • have hematocrit < 30% or > 52%
  • are on dialysis or have severe liver disease
  • are 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: Reassessment of Long-Term Dual Anti-Platelet Therapy Using InDividualized Strategies - Using a Novel Combined Demographic and Pharmacogenomic Strategy: The RAPID EXTEND Pilot Study

In patients with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Following PCI, standard preventative drug treatment includes the use of dual antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent clotting that can result in additional heart attacks, sudden clotting of stents or death.

New studies have shown that there is a benefit to continuing DAPT beyond this one year mark. Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the one year mark should be made on an individualized basis.

Read more

The present study is a "pilot study" that seeks to compare Long-Term use of Ticagrelor (LTT) versus a Personalized Approach (PA). We will be recruiting patients who have been stable (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a heart attack.

The PA group will use a modified DAPT score based on patient demographics to decide whether treatment is warranted. Patient will also undergo bedside genetic testing to identify potential at-risk genes. Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.

The present study will determine whether a personalized approach will decrease bleeding versus an approach of universal ticagrelor use.

The hypothesis is that patients receiving a personalized strategy will have a decreased risk of bleeding.

Being tested
Ticagrelor 60mg, Clopidogrel 75mg, Aspirin 81 mg

What participants receive

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

  • Ticagrelor 60mgDrug

    twice daily

  • Clopidogrel 75mgDrug

    once daily

  • Aspirin 81 mgDrug

    once daily

Study groups in NCT03224923
Study groupRoleWhat they receive
Personalized Treatment AlgorithmExperimentalA DAPT score using various patient demographics will be calculated: If score under 2, patients will receive only aspirin 81 mg once daily If DAPT score is ≥ 2 * A point-of-care bedside genetic test using a buccal swab will be conducted in order to determine medication regimen * Those with a positive genetic test (presence of CYP2C19*2 or CYP2C19*3), will receive 60mg Ticagrelor twice daily * Those with a negative genetic test (absence of CYP2C19*2/*3) will receive 75mg clopidogrel once daily
Receives: Drug: Ticagrelor 60mg; Drug: Clopidogrel 75mg; Drug: Aspirin 81 mg
Long-Term TicagrelorActive comparatorPatients will be given 60mg Ticagrelor twice daily with no aspirin
Receives: Drug: Ticagrelor 60mg

What is being measured

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

  1. Proportion of Patients with Decreased Bleeding Risk

    The primary endpoint is the proportion of patients with low on-treatment platelet reactivity (LPR) in the PA group compared to the LTT group at 1 month.

    • P2Y12 reactivity units (PRU) as a continuous variable will be measured using a VerifyNow P2Y12 assay
    • a PRU value of < 85 is associated with increased bleeding risk

    Measured: 1 month

Secondary outcomes (9)

  1. Platelet Reactivity Index (PRI) as a continuous variable

    Platelet function as measured by Vasodilator-stimulated phosphoprotein (VASP)

    • a PRI of < 16% is associated with increased bleeding risk

    Measured: 1 month

  2. ADP-induced Aggregation (AU) as a continuous variable

    Platelet function as measured by Multiplate analyzer

    • an AU of < 19 is associated with increased bleeding risk

    Measured: 1 month

  3. Bleeding according to Bleeding Academic Research Consortium (BARC) criteria

    the incidence and severity of bleeding as defined by BARC classification system

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  4. Bleeding according to Thrombolysis in Myocardial Infarction (TIMI) score

    the incidence and severity of bleeding as defined by TIMI classification systems

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  5. Bleeding according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria

    the incidence and severity of bleeding as defined by GUSTO classification systems

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  6. Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial).

    all-cause mortality incidence

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  7. Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial).

    recurrent myocardial infarction (MI) incidence

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  8. Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial).

    stroke incidence

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

  9. Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial).

    stent thrombosis incidence

    Measured: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years

Timeline

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

  1. First posted21 Jul 2017
  2. Study start18 Aug 2017
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Why it stopped: Competing study to be started in November 2018

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03224923
Sponsor's protocol ID
20170341
Status last verified
Jul 2019
First submitted
14 Jul 2017
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor 60mg, Clopidogrel 75mg and Aspirin 81 mg in people with Stable Coronary Syndrome and Percutaneous Coronary Intervention, 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 8 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 19 Jul 2019. 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: Competing study to be started in November 2018). 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?

Proportion of Patients with Decreased Bleeding Risk (time frame: 1 month). 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 NCT03224923.

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 19 Jul 2019.

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