Multinational Non-Interventional Study (NIS) of Patients with ST- Segment Elevation Myocardial Infarction Treated with Primary Angioplasty and Concomitant Use of Upstream Antiplatelet Therapy with a Thienopyridine Agent

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00003378
• Date of registration: 06/12/2011
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Europe GmbH
• Public title: Multinational Non-Interventional Study (NIS) of Patients with ST- Segment Elevation Myocardial Infarction Treated with Primary Angioplasty and Concomitant Use of Upstream Antiplatelet Therapy with a Thienopyridine Agent
• Scientific title: Multinational Non-Interventional Study (NIS) of Patients with ST- Segment Elevation Myocardial Infarction Treated with Primary Angioplasty and Concomitant Use of Upstream Antiplatelet Therapy with a Thienopyridine Agent - MULTIPRAC
• Date of first enrolment: 09/06/2011
• Target sample size: 2000
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00003378
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain

Contacts

• Name: Sabine Köhler
• Affiliation: Daiichi Sankyo Europe GmbH

• Name: Sabine Köhler
• Affiliation: Daiichi Sankyo Europe GmbH

Key inclusion & exclusion criteria

Inclusion criteria: • At least 18 years of age / • Started antiplatelet therapy with a thienopyridine agent upstream based on an initial STEMI diagnosis before arrival at the cathlab hospital according to the authorization of the drug or standard of care. / • Transported to the cathlab (study centre) hospital by ambulance with the intention to perform primary angioplasty (patients can be picked-up from home or from a referring hospital) / • Written informed consent for participation in the NIS / • No current or planned enrolment in a clinical study. Exception: Patients with current or planned enrolment in a clinical study can be included if all of the following conditions are met: a) The patient’s treatment with thienopyridine antiplatelet drugs is not determined by the clinical study protocol but is performed according to the terms of authorization of the drug or standard of care - b) The patient’s actual treatment with antiplatelet drugs and anticoagulants is fully known (i.e. not blinded according to the clinical study protocol).

Exclusion criteria: None

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

MedDRA - Acute myocardial infarction. Code: 10000891
I21

Acute myocardial infarction

Intervention(s)

Group 1: Observational group Thienopyridine pre-treated patients.
The following data will be recorded: Data related to demography, medical history, medical condition, the medication the patient receives (e.g. antiplatelet drugs), transfer details to the hospital, angiography and revascularisation results, hospitalization details, clinical data related to the diagnosis and treatment received, discharge information from the hospital.
A one year follow-up check of the patients health status will be performed.

Primary Outcome(s)

Inhospital efficacy and safety of pre-treatment with Thienopyridines. Survival up to one year after Diagnosis. Analysis and comparision of transport times between sites and countries accross Europe.

Secondary Outcome(s)

Not applicable

Secondary ID(s)

DSE-PRS-01-10

Source(s) of Monetary Support

Daiichi Sankyo Europe GmbH

Eli Lilly

Ethics review

Status: Approved
Approval date: 09/05/2011
Contact:

[e-mail]

Comité Etico de Investigacion Clinica de Galicia Edificio Administrativo de San Lazaro [Comité Etico de Investigacion Clinica de Galicia Edificio Administrativo de San Lazaro 15781 Santiago de Compostela [e-mail]]

[e-mail]

Results

• Date Completed: 23/06/2014
• URL: http://drks.de/search/en/trial/DRKS00003378#studyResults