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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944123
• Other study ID #: HOPE-TAILOR
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: June 2020

Study information

• Verified date: August 2020
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

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