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COMPLETED
NCT03487445
PHASE2

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

Summary

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Official title: A Multi-center, Open-label, Randomized, Study to Assess the Onset of Platelet Aggregation Inhibition After a Single Subcutaneous Injection of ACT-246475 in Adults With Acute Myocardial Infarction

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2018-07-10

Completion Date

2018-11-10

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

Selatogrel 8 mg

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.

DRUG

Selatogrel 16 mg

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.

Locations (6)

OLV Ziekenhuis Aalst

Aalst, Belgium

UZLeuven

Leuven, Belgium

Galilee Medical Center

Nahariya, Israel

Universitätsspital Basel

Basel, Switzerland

University Hospital Bern

Bern, Switzerland

Cardiocentro Ticino

Lugano, Switzerland