Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)

August 19, 2020 updated by: Moo Hyun Kim, Dong-A University

An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes

East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients present with acute coronary syndrome undergoing primary PCI.
  • Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month.
  • Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

  • Low body weight (<60kg).
  • History of transient ischemic attack or stroke.
  • History of upper gastrointestinal bleeding in recent 6 months.
  • Renal dysfunction defined as serum creatinine > 2.5 mg/dl
  • Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
  • On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
  • Bleeding tendency.
  • Thrombocytopenia defined by platelet < 100,000/ml.
  • Anemia defined by hemoglobin < 10 g/dl.
  • Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
  • Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
  • Contraindication for study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Clopidogrel 75 mg
Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose.
Drug: Clopidogrel 75 mg
Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.
Other Names:
  • Plavix 75 mg
EXPERIMENTAL: Prasugrel 5 mg
Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
Drug: Prasugrel 5 mg
Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
Other Names:
  • Effient 5 mg
EXPERIMENTAL: Ticagrelor 45 mg
Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
Drug: Ticagrelor 45 mg
Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
Other Names:
  • Brilinta 45 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal platelet reactivity (OPR) rate
Time Frame: At post-PCI 3 months.
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)
At post-PCI 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: Post-PCI 6 months.
MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke
Post-PCI 6 months.
Bleeding events
Time Frame: Post-PCI 6 months.
BARC: Bleeding Academic Research Consortium (BARC ≥2).
Post-PCI 6 months.
Drug side effects
Time Frame: Post-PCI 6 months.
Dyspnea or ventricular pauses ≥3 sec
Post-PCI 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (ESTIMATE)

October 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE-TAILOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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