Safety of KAI-9803 for Injection With Angioplasty Following Heart Attack

Myocardial Infarction Clinical Trial

Official title:

Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093197
• Other study ID #: KAI-9803-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2004
• Last updated: August 31, 2011
• Start date: September 2004
• Est. completion date: October 2006

Study information

• Verified date: August 2011
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenBrazil: National Health Surveillance AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients who have angioplasty may have ongoing damage to the heart muscle when the blockage is opened and blood flow is restored. Complications which may result from this ongoing damage include a larger area of damaged muscle in the heart, enlargement of the heart, an increased risk of death, and an increased risk of heart failure. Some of the ongoing damage may involve increased levels of the protein kinase C (PKC) enzyme. KAI-9803 is a selective inhibitor of delta PKC. In this study, delta PKC is used with angioplasty and other standard procedures to restore blood flow after a heart attack. This study is designed to evaluate safety of different amounts of KAI-9803 when used in treating heart attack patients undergoing angioplasty. We will also try to evaluate whether KAI-9803 can reduce the amount of heart muscle damage and the complications that may occur in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms of cardiac ischemia at rest or with increasing frequency (angina or angina equivalent), with episodes lasting for at least 30 minutes within 6 hours of presentation

• Persistent ST-segment elevation of = 0.2 mV in at least 2 contiguous precordial leads indicative of anterior Myocardial Infarction (MI) location (leads V1-V4)

• At least 18 years old

• Complete occlusion of the left anterior descending artery (Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow) demonstrated on the initial angiogram

• Culprit lesion suitable for primary percutaneous coronary intervention (PCI)

Exclusion Criteria:

• Any left bundle branch block (new or old), intraventricular conduction defect, or paced rhythm that would obscure the diagnosis of acute anterior ST Elevation Myocardial Infarction (STEMI)

• Any prior documented myocardial infarction (MI), including old Q waves documented on prior ECGs or a clinical history of definite MI

• Any prior coronary artery bypass grafting (CABG)

• Cardiogenic shock at initial hospital presentation, consisting of persistent hypotension (systolic blood pressure < 90 mm Hg for > 20 minutes) and signs of end-organ dysfunction (oliguria, altered mental status, poor peripheral perfusion, and lactic acidosis)

• TIMI grade 2 or 3 flow in the left anterior descending artery documented on the initial diagnostic angiogram

• Culprit lesion in the left anterior descending artery that is not suitable for primary PCI

• Treatment with intravenous fibrinolytic therapy (i.e. alteplase, reteplase, tenecteplase, or streptokinase) within the 24 hours before presentation

• Pregnancy

• Know baseline creatinine > 2.5 mg/dL without renal dialysis/renal replacement therapy within the 30 days before presentation

• Inability to comply with study procedures, inability to undergo cardiac catheterization or primary percutaneous coronary intervention (PCI)

• Participation in a study of experimental therapy (drug or device) within 30 days of presentation, or prior participation in this study

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• KAI-9803 for Injection
0.05 mg
• KAI-9803 for Injection
0.5 mg
• KAI-9803 for Injection
1.25 mg
• KAI-9803 for Injection
5 mg
• Placebo

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
KAI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		30 days	Yes
Primary	Number of participants with major cardiac events (death, congestive heart failure, recurrent myocardial infarction, repeat target vessel revascularization)		6 months	Yes
Secondary	Creatine kinase-myocardial band (CK-MB)		7 days or hospitalization discharge, whichever occurs first	No
Secondary	ST-segment elevation		24 hours	No
Secondary	Angiography vessel flow		Day 1	No
Secondary	Infarct size by single photon emission computed tomography (SPECT)		14 days	No
Secondary	Echocardiographic left ventricular ejection fraction (LVEF)		14 days	No