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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

KAI-9803 for Injection

Placebo

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

A1: KAI-9803

A2: KAI-9803

A3: KAI-9803

A4: KAI-9803

A5: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Number of participants with major cardiac events (death, congestive heart failure, recurrent myocardial infarction, repeat target vessel revascularization)

Secondary Outcome Measures

Creatine kinase-myocardial band (CK-MB)

ST-segment elevation

Angiography vessel flow

Infarct size by single photon emission computed tomography (SPECT)

Echocardiographic left ventricular ejection fraction (LVEF)

Full Information

NCT ID

NCT00093197

First Posted

October 4, 2004

Last Updated

August 31, 2011

Sponsor

KAI Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00093197

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KAI Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A1: KAI-9803

Arm Type

Experimental

Arm Title

A2: KAI-9803

Arm Type

Experimental

Arm Title

A3: KAI-9803

Arm Type

Experimental

Arm Title

A4: KAI-9803

Arm Type

Experimental

Arm Title

A5: Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

KAI-9803 for Injection

Intervention Description

0.05 mg

Intervention Type

Drug

Intervention Name(s)

KAI-9803 for Injection

Intervention Description

0.5 mg

Intervention Type

Drug

Intervention Name(s)

KAI-9803 for Injection

Intervention Description

1.25 mg

Intervention Type

Drug

Intervention Name(s)

KAI-9803 for Injection

Intervention Description

5 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

30 days

Title

Number of participants with major cardiac events (death, congestive heart failure, recurrent myocardial infarction, repeat target vessel revascularization)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Creatine kinase-myocardial band (CK-MB)

Time Frame

7 days or hospitalization discharge, whichever occurs first

Title

ST-segment elevation

Time Frame

24 hours

Title

Angiography vessel flow

Time Frame

Day 1

Title

Infarct size by single photon emission computed tomography (SPECT)

Time Frame

14 days

Title

Echocardiographic left ventricular ejection fraction (LVEF)

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Facility Information:

Facility Name

Duke Clinical Research Institute

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27715

Country

United States

Myocardial Infarction

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial