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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clopidogrel 75 mg

Prasugrel 5 mg

Ticagrelor 45 mg

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Half dose, Newer oral P2Y12 receptor inhibitors, Acute coronary syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dong-A University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Arm Label

Clopidogrel 75 mg

Prasugrel 5 mg

Ticagrelor 45 mg

Arm Description

Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose.

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.

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.

Outcomes

Primary Outcome Measures

Optimal platelet reactivity (OPR) rate

OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)

Secondary Outcome Measures

Major adverse cardiac and cerebrovascular events (MACCE)

MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke

Bleeding events

BARC: Bleeding Academic Research Consortium (BARC ≥2).

Drug side effects

Dyspnea or ventricular pauses ≥3 sec

Full Information

NCT ID

NCT02944123

First Posted

October 24, 2016

Last Updated

August 19, 2020

Sponsor

Dong-A University

1. Study Identification

Unique Protocol Identification Number

NCT02944123

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

February 2020 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Half dose, Newer oral P2Y12 receptor inhibitors, Acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Open-labeled

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel 75 mg

Arm Type

Other

Arm Description

Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose.

Arm Title

Prasugrel 5 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Ticagrelor 45 mg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Clopidogrel 75 mg

Other Intervention Name(s)

Plavix 75 mg

Intervention Description

Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.

Intervention Type

Drug

Intervention Name(s)

Prasugrel 5 mg

Other Intervention Name(s)

Effient 5 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 45 mg

Other Intervention Name(s)

Brilinta 45 mg

Intervention Description

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.

Primary Outcome Measure Information:

Title

Optimal platelet reactivity (OPR) rate

Description

OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)

Time Frame

At post-PCI 3 months.

Secondary Outcome Measure Information:

Title

Major adverse cardiac and cerebrovascular events (MACCE)

Description

MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke

Time Frame

Post-PCI 6 months.

Title

Bleeding events

Description

BARC: Bleeding Academic Research Consortium (BARC ≥2).

Time Frame

Post-PCI 6 months.

Title

Drug side effects

Description

Dyspnea or ventricular pauses ≥3 sec

Time Frame

Post-PCI 6 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moo Hyun Kim, MD

Organizational Affiliation

Dong-A University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dong-A University Hospital

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26376600

Citation

Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J. 2015;79(11):2452-60. doi: 10.1253/circj.CJ-15-0112. Epub 2015 Sep 16.

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

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