Clinical trial NCT02944123: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Half dose
Newer oral P2Y12 receptor inhibitors
Acute coronary syndrome
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Optimal platelet reactivity (OPR) rate
timeFrame: At post-PCI 3 months.
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: Post-PCI 6 months.
measure: Bleeding events
timeFrame: Post-PCI 6 months.
measure: Drug side effects
timeFrame: Post-PCI 6 months.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Moo Hyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.