Trial intelligence / Profile preview

Ticagrelor loading doses in STEMI

NCT01898442Phase 2

Key facts

Status
Completed
Start
Sep 2013
Primary completion
Jun 2014
Countries
1
Sponsor
University of Florida
Modality
Small Molecules
Conditions
coronary artery disease (CAD)
01

Overview

Phase 2, randomised, open-label trial of ticagrelor in coronary artery disease (CAD) (3 arms), sponsored by University of Florida. Primary endpoint: Platelet Reactivity by VerifyNow P2Y12 at 1 hour. Started Sep 2013; status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Ticagrelor 180

    Standard 180mg loading dose

  • Ticagrelor 270mg

    High 270mg loading dose

  • Ticagrelor 360mg

    High 360mg loading dose

03

Who it enrols

Patients with STEMI undergoing primary PCI, aged 18-80, with no prior P2Y12 use or high bleeding risk.

04

Endpoints

Primary

  • Platelet Reactivity by VerifyNow P2Y12

Secondary

  • Platelet Reactivity by VerifyNow P2Y12 at Other Time Points

  • Platelet Reactivity by Vasodilator-stimulated Phosphoprotein

  • Pharmacokinetic Profiles of Ticagrelor (Tmax)

  • Pharmacokinetic Profiles of Ticagrelor (Cmax)

  • Pharmacokinetic Profiles of Ticagrelor (AUC0-t)

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