Trial | NCT00093197  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    delcasertib ...

  • Study Participants

    154
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.
Study Started
Sep 30
2004
Primary Completion
Oct 31
2006
Study Completion
Oct 31
2006
Last Update
Sep 02
2011
Estimate

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

A1: KAI-9803 Experimental

A2: KAI-9803 Experimental

A3: KAI-9803 Experimental

A4: KAI-9803 Experimental

A5: Placebo Placebo Comparator

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 (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
No Results Posted