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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: KAI-9803 | Experimental |
| |
| A2: KAI-9803 | Experimental |
| |
| A3: KAI-9803 | Experimental |
| |
| A4: KAI-9803 | Experimental |
| |
| A5: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAI-9803 for Injection | Drug | 0.05 mg |
| |
| KAI-9803 for Injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Creatine kinase-myocardial band (CK-MB) | 7 days or hospitalization discharge, whichever occurs first | |
| ST-segment elevation | 24 hours | |
| Angiography vessel flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Institute | Durham | North Carolina | 27715 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C527142 | KAI 9803 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Drug |
0.5 mg |
|
| KAI-9803 for Injection | Drug | 1.25 mg |
|
| KAI-9803 for Injection | Drug | 5 mg |
|
| Placebo | Drug |
|
| Day 1 |
| Infarct size by single photon emission computed tomography (SPECT) | 14 days |
| Echocardiographic left ventricular ejection fraction (LVEF) | 14 days |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |