Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction

Zealand Pharma

Status and phase: Completed; Phase 2

Conditions: Focus of Study is STEMI

Treatments: Drug: danegaptide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01977755

13-031

Details and patient eligibility

About

This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.

Enrollment: 591 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• ST-segment elevation myocardial infarction
• Acute onset of chest pain of < 12 hours duration

Exclusion criteria

• Pregnancy
• Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
• Contraindication for cardiac MRI
• Inability to understand information or provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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591 participants in 3 patient groups, including a placebo group

danegapetide high dose

Active Comparator group

Description:

7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours

Treatment:

Drug: danegaptide

danegaptide low dose

Active Comparator group

Description:

2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours

Treatment:

Drug: danegaptide

Placebo

Placebo Comparator group

Description:

bolus injection, followed by infused over 6 hours

Treatment:

Drug: Placebo