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
1 other identifier
interventional
154
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 4, 2004
CompletedFirst Posted
Study publicly available on registry
October 7, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedSeptember 2, 2011
August 1, 2011
2.1 years
October 4, 2004
August 31, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events
30 days
Number of participants with major cardiac events (death, congestive heart failure, recurrent myocardial infarction, repeat target vessel revascularization)
6 months
Secondary Outcomes (5)
Creatine kinase-myocardial band (CK-MB)
7 days or hospitalization discharge, whichever occurs first
ST-segment elevation
24 hours
Angiography vessel flow
Day 1
Infarct size by single photon emission computed tomography (SPECT)
14 days
Echocardiographic left ventricular ejection fraction (LVEF)
14 days
Study Arms (5)
A1: KAI-9803
EXPERIMENTALA2: KAI-9803
EXPERIMENTALA3: KAI-9803
EXPERIMENTALA4: KAI-9803
EXPERIMENTALA5: Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke Clinical Research Institute
Durham, North Carolina, 27715, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2004
First Posted
October 7, 2004
Study Start
September 1, 2004
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
September 2, 2011
Record last verified: 2011-08