NCT04848220

A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).

Detailed description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to be conducted in 2 stages (Stage A and Stage B). Stage A is an ascending single-dose placebo-controlled study planned to consist of 2 cohorts. Stage B is a parallel-treatment group study planned to consist of a placebo group and 2 active treatment groups of temanogrel doses selected based on safety and tolerability data in Stage A.

Conditions

• Microvascular Obstruction

Interventions

Type	Name	Description
DRUG	Temanogrel	Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
DRUG	Placebo	Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-08-23
• Completion: 2022-08-31
• First posted: 2021-04-19
• Last updated: 2023-12-12
• Results posted: 2023-12-12

Locations

12 sites across 5 countries: United States, Australia, Netherlands, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study