NCT02071602

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

4.6 years

First QC Date

November 15, 2013

Last Update Submit

March 8, 2021

Conditions

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Keywords

Heart attackMyocardial InfarctionSTEMI

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with symptomatic hypotension

    baseline to 30 days

Secondary Outcomes (2)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo infused for up to 72 hours IV

Drug: CD-NP

CD-NP 5 ng/kg/min

ACTIVE COMPARATOR

CD-NP 5 ng/kg/min infused for up to 72 hours IV

Drug: CD-NP

CD-NP 10 ng/kg/min

PLACEBO COMPARATOR

CD-NP 10 ng/kg/min infused for up to 72 hours IV

Drug: CD-NP

Interventions

CD-NPDRUG

Randomized 1:1:1

Also known as: Cenderitide
CD-NP 10 ng/kg/minCD-NP 5 ng/kg/minPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant chest discomfort and /or shortness of breath
  • ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads
  • Successful reperfusion therapy (\>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography

You may not qualify if:

  • Cardiogenic shock, acute heart failure or hypotension (Systolic BP \< 90 mmHg)
  • Previous known decreased EF \< 40%
  • Atrial Fibrillation
  • Persistent signs and symptoms of Post MI ischemia
  • Requirement of pressors for maintenance of blood pressure.
  • Intra-aortic blood pump use
  • Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension.
  • Severe congenital heart diseases
  • Sustained ventricular tachycardia or ventricular fibrillation
  • Second or third degree heart block without a permanent cardiac pacemaker
  • Stroke within 3 months or other evidence of significantly compromised CNS perfusion
  • Total bilirubin of \> 2.5 mg/dL or other liver enzymes \>2.5 times the upper limit of normal if available clinically and measured within the last 7 days
  • Patients with calculated GFR \<30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days
  • Serum sodium of \< 125 mEq/dL or \> 160 mEq/dL if available clinically and measured within the last 7 days
  • Serum potassium of \< 3.0 mEq/dL or \> 5.8 mEq/dL if available clinically and measured within the last 7 days
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

cenderitide

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Horng Chen, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2013

First Posted

February 26, 2014

Study Start

October 1, 2013

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

US(1)