← Back to Search

Antiplatelet Agent

primary PCI for Heart Attack

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial

Summary

This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B. The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

Eligible Conditions
  • Heart Attack

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
Secondary study objectives
Number of Patients With All Cause Death and Non-fatal Stroke
Number of Patients With All Cause Death and Shock
Number of Patients With All Cause Death and Shock and CHF
+21 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: primary PCIExperimental Treatment1 Intervention
Standard primary PCI
Group II: TenecteplaseExperimental Treatment4 Interventions
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
primary PCI
2008
Completed Phase 4
~2110
Enoxaparin
FDA approved
catheterisation
2008
Completed Phase 3
~1900
Tenecteplase
FDA approved
Clopidogrel
FDA approved

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,856,227 Total Patients Enrolled
~107 spots leftby Nov 2025