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

Cardiovascular Diseases Clinical Trial

— PROTECTION AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785954
• Other study ID #: KAI-9803-004
• Secondary ID: EudraCT: 2008-00
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2008
• Last updated: August 30, 2011
• Start date: November 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: MedsafeBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEuropean Union: European Medicines AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1180
• Est. completion date: May 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Pathologic Processes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
KAI Pharmaceuticals	Bristol-Myers Squibb, Duke University, The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  Denmark,  Finland,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of KAI-9803 on infarct size as assessed by CK-MB AUC		During the index hospitalization	No
Secondary	The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias		Within the first 3 months after Myocardial Infarction	No
Secondary	The safety and tolerability of KAI-9803 by IV infusion to acute STEMI		Within the first 3 months after Myocardial Infarction	No
Secondary	Assess left ventricular function by imaging		Within the first 3 months after Myocardial Infarction	No