Clinical trial NCT00212030: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Official title: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Data mining
Nicorandil
Randomized clinical trial
SNPs
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

Detailed description: The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, nicorandil, a hybrid of an ATP-sensitive K+ (KATP) channel opener and nitrates, reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP) designed a prospective, randomized, multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for AMI.

Twenty-six hospitals in Japan are participating in the J-WIND-KATP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo. The primary end-points are (1) estimated infarct size and (2) left ventricular function. Single nucleotide polymorphisms (SNPs) that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined. Furthermore, a data mining method will be used to design the optimal combined therapy for post-myocardial infarction (MI) patients.

It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.

Eligibility criteria: Inclusion Criteria:

1. Age 20-79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Exclusion Criteria:

1. History of old myocardial infarction
2. Left main coronary artery stenosis
3. Severe liver and/or kidney dysfunction
4. Suspected aortic dissection
5. History of coronary artery bypass graft
6. History of allergic response to drugs
7. Severe hypovolemia
8. Right ventricular infarction

Primary outcomes:
measure: estimated infarct size
timeFrame: 72hrs
measure: left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
timeFrame: 2-8weeks and 6-12months
Secondary outcomes:
measure: survival rate
timeFrame: 2.7years (median follow-up)
measure: cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
timeFrame: 2.7years (median follow-up)
measure: reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
timeFrame: 24hrs
measure: the association of SNPs of ANP-related genes with response to ANP treatment
timeFrame: 2.7years (median follow-up)
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
Study officials:
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Masafumi Kitakaze, MD, PhD
role: STUDY_CHAIR
References:
citation: Minamino T, Jiyoong K, Asakura M, Shintani Y, Asanuma H, Kitakaze M; J-WIND Investigators. Rationale and design of a large-scale trial using nicorandil as an adjunct to percutaneous coronary intervention for ST-segment elevation acute myocardial infarction: Japan-Working groups of acute myocardial infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP). Circ J. 2004 Feb;68(2):101-6. doi: 10.1253/circj.68.101.