NCT00212056

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

October 31, 2007

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionAtrial natriuretic peptideData miningRandomized clinical trialSNPs

Outcome Measures

Primary Outcomes (2)

  • estimated infarct size

    72hrs

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

    2-8weeks and 6-12months

Secondary Outcomes (4)

  • survival rate

    2.7years (median follow-up)

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

    2.7years (median follow-up)

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

    24hrs

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

    2.7years (median follow-up)

Study Arms (2)

ANP

ACTIVE COMPARATOR
Drug: ANP(hANP)

Control

PLACEBO COMPARATOR
Drug: Control

Interventions

ANP(hANP)DRUG

0∙025 μg/kg per min for 3 days(intravenous)

ANP
ControlDRUG

placebo

Control

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-79 years
  • Chest pain of more than 30 min
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center

Suita, Osaka, 544-0024, Japan

Location

Related Publications (1)

  • 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.

    PMID: 14745142BACKGROUND

Study Officials

  • Masafumi Kitakaze, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2001

Study Completion

December 1, 2005

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

JP(1)