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

NCT02944123 | Completed Phase 3 DMC

• 1 other identifier: HOPE-TAILOR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  At post-PCI 3 months.

Secondary Outcomes (3)

• Major adverse cardiac and cerebrovascular events (MACCE)

  Post-PCI 6 months.

• Bleeding events

  Post-PCI 6 months.

• Drug side effects

  Post-PCI 6 months.

Study Arms (3)

Clopidogrel 75 mg

OTHER

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

Drug: Clopidogrel 75 mg

Prasugrel 5 mg

EXPERIMENTAL

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

Ticagrelor 45 mg

EXPERIMENTAL

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

Interventions

Clopidogrel 75 mg DRUG

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

Also known as: Plavix 75 mg

Clopidogrel 75 mg

Prasugrel 5 mg DRUG

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.

Also known as: Effient 5 mg

Prasugrel 5 mg

Ticagrelor 45 mg DRUG

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.

Also known as: Brilinta 45 mg

Ticagrelor 45 mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26376600 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Moo Hyun Kim, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-labeled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 25, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

KR (1)