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

Sponsored by:	KAI Pharmaceuticals
Information provided by:	KAI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00093197

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: KAI-9803 for Injection	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:

Safety

Estimated Enrollment:	150
Study Start Date:	September 2004
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093197

Locations

United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27715

Sponsors and Collaborators

KAI Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	KAI-9803-001
Study First Received:	October 4, 2004
Last Updated:	April 25, 2006
ClinicalTrials.gov Identifier:	NCT00093197 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Brazil: National Health Surveillance Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Poland: Central Register of Clinical Trials; United States: Food and Drug Administration

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on August 13, 2009