Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03487445
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487445
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The goal of this study is to find out how fast a drug called 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 ACT-246475 will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: ACT-246475 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: ACT-246475 - 8 mg
Single s.c. administration
Drug: ACT-246475
ACT-246475 for s.c. administration will be available as sealed glass vials in 20 mg strength

Experimental: ACT-246475 - 16 mg
Single s.c. administration
Drug: ACT-246475
ACT-246475 for s.c. administration will be available as sealed glass vials in 20 mg strength




Primary Outcome Measures :
  1. Response to the treatment defined for each subject as a P2Y12 reaction units value < 100 at the 30 min post-dose time point, as measured via VerifyNow®. This corresponds to an inhibition of ADP-induced platelet aggregation > 80%. [ Time Frame: 30 min post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Informed consent obtained prior to any study-mandated procedure,
  • Males aged from 18 to 85 and postmenopausal females aged up to 85 years,
  • Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization,
  • Subjects presenting a type I AMI including STEMI or NSTEMI.

Main Exclusion Criteria:

  • Cardiogenic shock or severe hemodynamic instability,
  • Cardiopulmonary resuscitation,
  • Loading dose of any oral P2Y12 receptor antagonist prior to randomization,
  • Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization,
  • Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487445


Locations
Layout table for location information
Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
UZLeuven
Leuven, Belgium, 3000
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
University Hospital Bern
Bern, Switzerland, 3010
Cardiocentro Ticino
Lugano, Switzerland, 6900
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03487445    
Other Study ID Numbers: ID-076A202
2018-000765-36 ( EudraCT Number )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases