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Completed

NCT Number: NCT00212030

Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

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

Completed

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Key information

Conditions

Acute Myocardial Infarction

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • History of old myocardial infarction
  • Left main coronary artery stenosis
  • Severe liver and/or kidney dysfunction
  • Suspected aortic dissection
  • History of coronary artery bypass graft
  • History of allergic response to drugs
  • Severe hypovolemia
  • Right ventricular infarction

Treatment and study plan

nicorandil

Drug

(0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion

Placebo

Drug

Control

Primary outcomes

  1. estimated infarct size

    Time frame: 72hrs

  2. left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion

    Time frame: 2-8weeks and 6-12months

Secondary outcomes

  1. survival rate

    Time frame: 2.7years (median follow-up)

  2. cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)

    Time frame: 2.7years (median follow-up)

  3. reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)

    Time frame: 24hrs

  4. the association of SNPs of ANP-related genes with response to ANP treatment

    Time frame: 2.7years (median follow-up)

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Registry information

Important dates

Study start
2001
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Nov 1, 2007

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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