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The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.
This is a "proof of concept", randomized, double-blind, placebo controlled study. The study population will include 60 patients admitted with a first time ST elevation anterior STEMI as diagnosed by the following criteria: a) Significant chest discomfort and /or shortness of breath; b) ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads; c) Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or PTCA within 24 hours of onset of symptoms as documented by coronary angiography; and d) No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI.
Patients will be randomized to one of two doses of CD-NP (5 ng/kg/min and 10 ng/kg/min) or placebo continuous infusion for up to 72 hours in a 1:1:1 manner. All patients will receive other standard medical therapies as determined appropriate by the physician and in accordance to the ACC/AHA guidelines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo infused for up to 72 hours IV |
|
| CD-NP 5 ng/kg/min | Active Comparator | CD-NP 5 ng/kg/min infused for up to 72 hours IV |
|
| CD-NP 10 ng/kg/min | Placebo Comparator | CD-NP 10 ng/kg/min infused for up to 72 hours IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD-NP | Drug | Randomized 1:1:1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with symptomatic hypotension | baseline to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of LV function improvement between placebo vs. CD-NP groups | baseline to 30 days | |
| Exploratory analyses of Major Adverse Cardiovascular Events (MACE) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:(Assessed at the time of enrollment unless otherwise stated)
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| Name | Affiliation | Role |
|---|---|---|
| Horng Chen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C575835 | cenderitide |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |