NCT00093197

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: KAI Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	KAI-9803 for Injection	0.05 mg
DRUG	KAI-9803 for Injection	0.5 mg
DRUG	KAI-9803 for Injection	1.25 mg
DRUG	KAI-9803 for Injection	5 mg
DRUG	Placebo

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2004-10-07
• Last updated: 2011-09-02

Locations

1 site across 1 country: United States