Clinical trial NCT02446730: Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
Official title: A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Death
Hemorrhage
Cerebrovascular Accident
Myocardial Infarction
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.

Detailed description: About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial.

These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES .

The investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure.

Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.

Eligibility criteria: Inclusion Criteria:

* Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke,
* 75 years old or younger,
* body weight of 60 kg or more and diagnosed with acute coronary syndrome

Exclusion Criteria:

* Patients with history of TIA or stroke,
* 75 years old or older,
* body weight of 60 kg or under,
* hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media

Primary outcomes:
measure: A compoiste of cardiac death, non-fatal myocardiac infarction and stroke
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
Secondary outcomes:
measure: All-cause death
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: Cardiac death
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: non-fatal myocardial infarction
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: Stroke
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: Target lesion revascularization
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: stent thrombosis
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
measure: BARC bleeding 2,3,and 5
timeFrame: within the 1 year after BIOMATRIXTM Stent implantation
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Jung-Me Lee
Study officials:
affiliation: Chonnam National University Hospital
name: Myung Ho Jeong, PhD
role: PRINCIPAL_INVESTIGATOR
References: