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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00093197
First received: October 4, 2004
Last updated: August 31, 2011
Last verified: August 2011
  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
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Number of participants with major cardiac events (death, congestive heart failure, recurrent myocardial infarction, repeat target vessel revascularization) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Creatine kinase-myocardial band (CK-MB) [ Time Frame: 7 days or hospitalization discharge, whichever occurs first ] [ Designated as safety issue: No ]
  • ST-segment elevation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Angiography vessel flow [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Infarct size by single photon emission computed tomography (SPECT) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Echocardiographic left ventricular ejection fraction (LVEF) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: September 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1: KAI-9803 Drug: KAI-9803 for Injection
0.05 mg
Experimental: A2: KAI-9803 Drug: KAI-9803 for Injection
0.5 mg
Experimental: A3: KAI-9803 Drug: KAI-9803 for Injection
1.25 mg
Experimental: A4: KAI-9803 Drug: KAI-9803 for Injection
5 mg
Placebo Comparator: A5: Placebo Drug: Placebo

  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 (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
  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

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00093197     History of Changes
Other Study ID Numbers: KAI-9803-001
Study First Received: October 4, 2004
Last Updated: August 31, 2011
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: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014