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Completed

NCT Number: NCT00785954

Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]

The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bedford Park, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute STEMI and has a planned emergent primary PCI procedure
  • Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset

Exclusion criteria

  • Persistent systolic blood pressure < 90 mm Hg

Treatment and study plan

KAI-9803

Drug

STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

Primary outcomes

  1. The effect of KAI-9803 on infarct size as assessed by CK-MB AUC

    Time frame: During the index hospitalization

Secondary outcomes

  1. The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias

    Time frame: Within the first 3 months after Myocardial Infarction

  2. The safety and tolerability of KAI-9803 by IV infusion to acute STEMI

    Time frame: Within the first 3 months after Myocardial Infarction

  3. Assess left ventricular function by imaging

    Time frame: Within the first 3 months after Myocardial Infarction

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Collaborators

  • Bristol-Myers Squibb
  • Duke University
  • The Cleveland Clinic

Registry information

Official study title

Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

Acronym: PROTECTION AMI

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Nov 5, 2008
Registry last updated
Sep 2, 2011

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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