to study search History

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

Organizational Data

DRKS-ID:
DRKS00003378
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2011-12-06
Last update in DRKS:
2020-06-02
Registration type:
Retrospective

Acronym/abbreviation of the study

MULTIPRAC

URL of the study

No Entry

Brief summary in lay language

The purpose of this observational study is to collect data in patients with heart attacks under real-life conditions, namely on the early start of an antiplatelet therapy directly after the diagnosis of heart attack has been made. Patients suffering from heart attack where the blood flow in one or more coronary arteries is completely blocked by a blood clot are eligible. These patients must have received an initial loading dose of an antiplatelet drug to prevent further blood clots and potential re-infarction directly after their heart attack was diagnosed. The initial diagnosis was done either in the ambulance car or a referring hospital, the loading dose was applied directly after the diagnosis and before or during transport to the hospital in which the intervention (opening of the blocked aretery) is performed. All medical treatments will be performed according to the standard of care and no additional examinations will be performed. The study is purely observational and only collects already existing data or data collected in the course of the routine treatment for the heart attack. The study team will contact the patient or relatives or treating doctor in one year to check the health status, after one year the participation in the study will be completed.

Brief summary in scientific language

The objective of this NIS is to gain further insight under real life conditions on STEMI patients scheduled for primary angioplasty who received an upstream loading dose of antiplatelet therapy after initial STEMI diagnosis and before admission to the cathlab.

Health condition or problem studied

Free text:
MedDRA - Acute myocardial infarction. Code: 10000891
ICD10:
I21 - Acute myocardial infarction
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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 patient's health status will be performed.

Endpoints

Primary outcome:
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:
Not applicable

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
Number of study centers:
Multicenter study
Recruitment location(s):
No Entry

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2011-06-09
Planned study completion date:
No Entry
Actual Study Completion Date:
2014-06-23
Target Sample Size:
2000
Final Sample Size:
2095

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

Daiichi Sankyo Europe GmbH
Zielstattstr. 48
81379 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Daiichi Sankyo Europe GmbH
Sabine Köhler
Zielstattstr. 48
81379 München
Germany
Telephone:
+49897808-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Daiichi Sankyo Europe GmbH
Sabine Köhler
Zielstattstr. 48
81379 München
Germany
Telephone:
+49897808-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Daiichi Sankyo Europe GmbH
Sabine Köhler
Zielstattstr. 48
81379 München
Germany
Telephone:
+49897808-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Eli Lilly
Werner-Reimers-Straße 2-4
61352 Bad Homburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Daiichi Sankyo Europe GmbH
Zielstattstr. 48
81379 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

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 ceic@sergas.es]
15781 Santiago de Compostela
Spain
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2011-04-04
Ethics committee number:
EC Galicia Registry: 2011/141
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-05-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
No Entry
Other secondary IDs:
DSE-PRS-01-10 - Italy: rso (Registro Studi Osservazionali) AIFA
Other secondary IDs:
DSE-PRS-01-10 - sponsor-id - Daiichi Sankyo study No.
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
European Heart Journal: Acute Cardiovascular Care 2048872614547449, first published on September 2, 2014 as doi:10.1177/2048872614547449
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry