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Myocardial InfarctionPhase 3ETAMINCT01327534

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

A Phase 3 study testing Prasugrel and Clopidogrel in people with Myocardial Infarction and STEMI, run by Stiftung Institut fuer Herzinfarktforschung at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Myocardial Infarction, STEMI
What is being tested?
Prasugrel and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
3 sitesin 2 countries
Study dates
May 2011to Jul 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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")

Who cannot join

  • Age ≥ 75 years
  • Body weight < 60 kg
  • Thrombolytic therapy within 24 hours before randomization
  • Oral anticoagulation
  • Known hemorrhagic diathesis
  • History of Stroke or TIA
Show all 19Show fewer
  • 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
  • Uncontrollable hypertension (blood pressure ≥ 200/110 mmHg in repeated measurements)
  • Treatment with NSAIDs
  • Participation in another clinical or device trial within the previous 30 days
  • First medical contact in a PCI-hospital (this criterion was changed by a protocol amendment in autumn 2012 to "Expected time between administration of loading dose and start of PCI is < 20 minutes")

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • Charité Campus Benjamin Franklin, Med. Klinik II

    Berlin, 12203

  • Klinikum Ludwigshafen, Med. Klinik B

    Ludwigshafen, 67063

Other trials in Germany

France1 site

  • Hospital Pitie-Salpetriere

    Paris, 75013

Other trials in France

About this study

Official title: ETAMI-Study: Early Thienopyridine Treatment to Improve Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

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.

Read the detailed description

This could be achieved by either thrombolytic therapy or primary Percutaneous coronary intervention (PCI).

Comparison of the different therapies in randomized trials shows an advantage of primary PCI regarding rates of recanalisation of the infarct vessel, preservation of left ventricular (LV) function, and reduction in the rate of reinfarctions. In addition, the in-hospital mortality is lower in patients undergoing primary PCI. Nevertheless, primary PCI does not always result in a successful reperfusion despite of successful restoration of blood flow in the epicardial infarct related artery.

Effective platelet inhibition is a cornerstone of therapy in patients with STEMI. In the ISIS-2 study acetylsalicylic acid (ASA) has been shown to improve short- and long-term clinical outcome in the same extent as fibrinolysis with streptokinase. Dual platelet inhibition with ASA and a thienopyridine has been repeatedly demonstrated to be more effective than ASA alone. Clopidogrel on top of ASA improved outcome in patients with acute coronary syndromes with and without PCI in the CURE study. Furthermore, a loading dose of 300 mg clopidogrel was advantageous in elective PCI in the CREDO trial and the addition of clopidogrel to ASA improved the patency rate of the infarct related artery in patients with STEMI undergoing fibrinolysis. In the BRAVE 3 study, the addition of abciximab to a background therapy of a high loading dose of 600 mg clopidogrel plus ASA did not result in an additional clinical benefit in terms of prevention of ischemic complications in primary elective PCI, suggesting a near optimal platelet inhibition with this treatment in primary PCI. The advantage of a 600 mg loading dose seems mainly related to the more rapid onset of the full antiplatelet effect within 2-4 hours as compared to 6-8 hours after 300 mg.

However, in patients with STEMI scheduled for primary PCI an earlier effective inhibition of ADP-induced platelet aggregation, preferably within 60-90 min after administration of the drug, is needed.

The new thienopyridine prasugrel has been shown to achieve a more complete and even more rapid platelet inhibition compared to clopidogrel. This might be especially important in patients with STEMI scheduled for primary PCI. In these patients activation of platelets is more pronounced compared to patients undergoing PCI for stable CAD.

In a small substudy of the TRITON-TIMI 38 trial inhibition of platelet aggregation measured with the VASP assay was more effective with prasugrel than with clopidogrel. However, this substudy was done predominantly in patients with unstable angina and NSTEMI. In addition, none of these patients were treated in the pre-hospital phase. Therefore it is necessary to determine if in patients with acute STEMI an early administration of a high loading dose of prasugrel in comparison with clopidogrel before planned primary PCI improves the inhibition of platelet aggregation, therefore facilitates this procedure and results in an improved myocardial reperfusion before and after PCI.

Being tested
Prasugrel, Clopidogrel
Keywords
STEMI, clopidogrel, prasugrel, platelet reactivity index, ST resolution
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrasugrelDrug

    Also called Effient, Efient

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

  • ClopidogrelDrug

    Also called Plavix

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

Study groups in NCT01327534
Study groupRoleWhat they receive
prasugrelExperimentaltreatment with a 60 mg loading dose prasugrel, followed by a maintenance dose of 10 mg for 30 days
Receives: Drug: Prasugrel
clopidogrelActive comparatortreatment with a 600 mg loading dose clopidogrel, followed by a maintenance dose of 75 mg for 30 days
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 hours after initiation of therapy

Secondary outcomes (11)

  1. platelet reactivity index 4 hours after initiation of therapy

    Measured: 4 hours after initiation of therapy

  2. 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

    Measured: 60 min after PCI

  3. 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

    Time frame: expected average. In general: "immediately prior to PCI"

    Measured: 1 hour after initiation of therapy

  4. TIMI 3 patency before PCI

    Time frame: expected average. In general: "before PCI"

    Measured: 1 hour after initiation of therapy

  5. TIMI 3 patency after PCI

    Time frame: expected average. In general: "after PCI"

    Measured: 2 hours after initiation of therapy

  6. ST resolution immediately before angiography

    Time frame: expected average. In general: "immediately before angiography"

    Measured: 1 hour after initiation of therapy

  7. partial or no ST resolution 60 minutes after PCI

    Measured: 60 minutes after PCI

  8. ST segment deviation 60 minutes after PCI

    Measured: 60 minutes after PCI

  9. death, re-MI, stent thrombosis and urgent revascularisation until 48 hours, day 7 and 30 days

    Measured: 48 hours, day 7, day 30

  10. stroke (hemorrhagic, non-hemorrhagic)

    Measured: day 30

  11. severe bleeding complications according to the TIMI and GUSTO classifications

    Measured: day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMar 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327534
Sponsor's protocol ID
ETAMI
Acronym
ETAMI
Status last verified
Jun 2016
First submitted
29 Mar 2011
Last updated
17 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 25616919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasugrel and Clopidogrel in people with Myocardial Infarction and STEMI, run by Stiftung Institut fuer Herzinfarktforschung at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

platelet reactivity index (PRI) measured by VASP phosphorylation (time frame: 2 hours after initiation of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.

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