Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute MI

NCT01327534 | Completed Phase 3 DMC

• 1 other identifier: ETAMI
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 3

Brief Summary

Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium.

Conditions

Myocardial Infarction; STEMI

Keywords

STEMI; clopidogrel; prasugrel; platelet reactivity index; ST resolution

Outcome Measures

Primary Outcomes (1)

• platelet reactivity index (PRI) measured by VASP phosphorylation

  The primary endpoint is the platelet reactivity index (PRI) measured by VASP phosphorylation 2 hours after the initiation of the therapy. The VASP assay was chosen because it is not influenced by the concomitant administration of GP IIb/IIIa inhibitors, which are expected to be given in 50-60% of STEMI patients.

  2 hours after initiation of therapy

Secondary Outcomes (11)

• platelet reactivity index 4 hours after initiation of therapy

  4 hours after initiation of therapy

• rate of complete (> 70%) ST segment resolution 60 minutes after PCI as assessed by an ECG core laboratory which is blinded to the treatment group

  60 min after PCI

• TIMI 2/3 patency of the infarct-related artery immediately prior to PCI done by an angiography core reading centre which is blinded to treatment group

  1 hour after initiation of therapy

• TIMI 3 patency before PCI

  1 hour after initiation of therapy

• TIMI 3 patency after PCI

  2 hours after initiation of therapy

Study Arms (2)

prasugrel

EXPERIMENTAL

treatment with a 60 mg loading dose prasugrel, followed by a maintenance dose of 10 mg for 30 days

Drug: Prasugrel

clopidogrel

ACTIVE COMPARATOR

treatment with a 600 mg loading dose clopidogrel, followed by a maintenance dose of 75 mg for 30 days

Drug: Clopidogrel

Interventions

Prasugrel DRUG

treatment with a 60 mg loading dose prasugrel, followed by a maintenance dose of 10 mg for 30 days

Also known as: Effient, Efient

prasugrel

Clopidogrel DRUG

treatment with a 600 mg loading dose clopidogrel, followed by a maintenance dose of 75 mg for 30 days

Also known as: Plavix

clopidogrel

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 75 years
• Acute STEMI ≤ 12 h defined as 1. Angina or equivalent symptoms \> 30 min and 2. ST elevation ≥ 2 leads (≥ 2 mm precordial leads, ≥ 1 mm limb leads) or ST depression ≥ 1 mm precordial leads in posterior MI
• planned percutaneous coronary intervention
• legal capacity
• informed consent
• first medical contact in the prehospital setting or in a non-PCI hospital (this criterion was changed by a protocol amendment in autumn 2012 to "first medical contact in the prehospital setting, in a non-PCI hospital, or in a PCI-hospital, if the expected time until the start of the scheduled PCI is at least 20 minutes")

You may not qualify if:

• Age ≥ 75 years
• Body weight \< 60 kg
• Thrombolytic therapy within 24 hours before randomization
• Oral anticoagulation
• Known hemorrhagic diathesis
• History of Stroke or TIA
• Cardiogenic shock
• Evidence of an active gastrointestinal or urogenital bleeding
• Major surgery within 6 weeks
• Contraindication to prasugrel or clopidogrel
• Severe renal or hepatic insufficiency
• Contraindication to coronary angiography
• Planned administration of a GP IIb/IIIa-Inhibitor before angiography
• Pregnant or nursing (lactating) women
• Patients currently (within the last 10 days) treated with clopidogrel, prasugrel, ticlopidine, or ticagrelor

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Daiichi Sankyo: collaborator

Study Sites (3)

Hospital Pitie-Salpetriere

Paris, 75013, France

Location

Charité Campus Benjamin Franklin, Med. Klinik II

Berlin, 12203, Germany

Location

Klinikum Ludwigshafen, Med. Klinik B

Ludwigshafen, 67063, Germany

Location

Related Publications (1)

• Zeymer U, Mochmann HC, Mark B, Arntz HR, Thiele H, Diller F, Montalescot G, Zahn R. Double-blind, randomized, prospective comparison of loading doses of 600 mg clopidogrel versus 60 mg prasugrel in patients with acute ST-segment elevation myocardial infarction scheduled for primary percutaneous intervention: the ETAMI trial (early thienopyridine treatment to improve primary PCI in patients with acute myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):147-154. doi: 10.1016/j.jcin.2014.09.007. Epub 2014 Nov 4.

  PMID: 25616919 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Uwe Zeymer, MD

  Klinikum Ludwigshafen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 1, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); FR (1)