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Completed

NCT Number: NCT02944123

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

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).

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dong-A University Hospital

Busan, 602-715, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clopidogrel 75 mg

Drug

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

Other names: Plavix 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.

Other names: Effient 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.

Other names: Brilinta 45 mg

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Bleeding events

    Time frame: Post-PCI 6 months.

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

  3. Drug side effects

    Time frame: Post-PCI 6 months.

    Dyspnea or ventricular pauses ≥3 sec

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2016
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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