A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

Summary

The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.

Timeline

Start

2018-01-24

Primary completion

2018-08-18

Completion

2018-09-18

Outcome

Met primary endpoint

registry analysis (superiority test); Selatogrel 8 mg vs Placebo; p < 0.0001; Odds Ratio (OR) 58.9 (97.5% CI 22.4 to 154.8); NCT03384966 ↗

registry analysis (superiority test); Selatogrel 16 mg vs Placebo; p < 0.0001; Odds Ratio (OR) 61.2 (97.5% CI 23.1 to 162.3); NCT03384966 ↗

Publications

• Storey RF, Gurbel PA, Ten Berg J, Bernaud C, Dangas GD, Frenoux JM, Gorog DA, Hmissi A, Kunadian V, James SK, Tanguay JF, Tran H, Trenk D, Ufer M, Van der Harst P, Van't Hof AWJ, Angiolillo DJ. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. Eur Heart J. 2020 Sep 1;41(33):3132-3140. doi: 10.1093/eurheartj/ehz807.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selatogrel	Small molecule	8 mg	Subcutaneous
Subject	Selatogrel	Small molecule	16 mg	Subcutaneous

Indications