Phase 4
N=390
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Heart Disease · Myocardial Infarction · Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00178620 ↗Enrolled (actual)
390
Serious AEs
3.3%
Results posted
Sep 2023
Primary outcome: Primary: Mortality at 30 Days — 1; 7; 3; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Reteplase 10 Units (U) plus a second dose of reteplase 10 U (Drug); Reteplase 10 U (Drug); Urgent Percutaneous Coronary Intervention (PCI) (Procedure); Primary Percutaneous Coronary Intervention (PCI) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality at 30 Days |
1; 7; 3; 2 | — |
| SECONDARY Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Reduction in Time From Onset of Pain to Reperfusion |
— | — |
| SECONDARY Angiographic Documentation of Reperfusion |
— | — |
| SECONDARY Electrocardiogram (ECG) ST Segment Elevation Recovery |
— | — |
Summary
The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital use of a "clot busting" (thrombolytic) drug followed with emergent heart catheterization including stenting of the problematic coronary artery, will result in a lower mortality and reduced repeat heart attack rates.
Early identifying and treating heart attacks patients prior to the arriving at the hospital, in those patients who qualify for the "clot busting" drugs will lower the size of the heart attack damage. This smaller heart attack will lead to fewer problems with less repeat heart attacks and death in the future.
Eligibility Criteria
Inclusion Criteria
- Ischemic discomfort (squeezing, crushing, or pressure, sub-sternal, unrelated to breathing or movement), epigastric discomfort or pre-syncopal symptoms with diaphoresis, lasting > 30 minutes.
- ST elevation > 0.1 mV in 2 or more contiguous limb leads or > 0.2 mV in 2 or more contiguous pre-cordial leads.
- Less than 6 hours after onset of sustained chest pain.
- Age 18 years or older.
Exclusion Criteria
- Chest pain described as ripping or tearing, radiating to the back and/or down the leg, and/or systolic blood pressure > 15 mmHg difference in each arm.
- Suspected cocaine or amphetamine use within previous 3 days.
- Known or suspected pregnancy.
- Cardiac arrest requiring intubation.
- Cardiac arrest requiring greater than 20 minutes CPR.
- Coronary intervention (PTCA/stent/CABG) within previous 4 weeks.
Data sourced from ClinicalTrials.gov (NCT00178620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.