Heart DiseasePhase 4PATCARNCT00178620
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
A Phase 4 study testing Reteplase 10 Units (U) plus a second dose of reteplase 10 U, Reteplase 10 U and Urgent Percutaneous Coronary Intervention (PCI) in people with Heart Disease and Myocardial Infarction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Myocardial Infarction, Acute Myocardial Infarction
- What is being tested?
- Reteplase 10 Units (U) plus a second dose of reteplase 10 U, Reteplase 10 U and Urgent Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital / The University of Texas HSC
Houston, Texas, 77030
About this study
Official title: PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
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.
Read the detailed description
To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500 patients to pre-hospital thrombolysis/clot busting followed by emergent catheterization and stenting of the problematic or culprit artery.
This will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent transportation to a Level I Cardiovascular Center where the patients will be taken to urgent cardiac catheterization and emergent stenting of the culprit artery.
Patients identified as having typical symptoms of acute MI and an ECG consistent with acute ST elevation MI will be screened in the field by paramedics or in the spoke hospitals by the ED attending physicians using the screening form. Verbal Consent will be obtained for receiving acute therapy for their MI as outlined in the protocol. After therapy is initiated in the field or at the spoke hospital, the patients will be transported as quickly as possible to the receiving Level I Cardiovascular Center (Hub Hospital). The ED personnel in the Level I Cardiovascular Center will have activated the Interventional Cardiovascular Team and the Cath Lab personnel after having received the initial qualifying transmitted ECG.
Once the patient arrives, informed consent will be obtained by the ED investigator and/or in-house Cardiology fellow for enrollment in the PATCAR Trial. Thrombolytic ineligible patients will also be collect for this study and also go directly to the Cath Lab for PCI. Study coordinators will enter the data into the Case Report Forms and forward the completed forms to Westat-ALA for data capture in the database. In addition to the qualifying ECG, ECG's will be obtained at hospital discharge/transfer. All patients will follow the current standard of care for STEMI/heart attacks patients. Patients will have a Cardiac MRI done on day 3 or 5 of their hospital stay, to measure the size and amount of damage the heart suffered as a result of their Heart attack.
- Being tested
- Reteplase 10 Units (U) plus a second dose of reteplase 10 U, Reteplase 10 U, Urgent Percutaneous Coronary Intervention (PCI), Primary Percutaneous Coronary Intervention (PCI)
- Keywords
- Heart Disease, Heart Attack, Myocardial Infarction, Thrombolytic Therapy, Emergency Medicine
- Medical subject headings
- Heart Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reteplase 10 Units (U) plus a second dose of reteplase 10 UDrug
Also called Retavase
Thrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose
Reteplase 10 UDrug
Also called Retavase
Thrombolytic-clot busting drug Retavase IV Bolus in one 10U dose
Urgent Percutaneous Coronary Intervention (PCI)Procedure or surgery
Primary Percutaneous Coronary Intervention (PCI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A: Full dose pre-hospital fibrinolysis | Experimental | Patients transported by participating EMS units and that were fibrinolytic eligible and treated with full dose, pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase and randomized to a second 10-unit dose of reteplase). Receives: Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 U |
| Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI | Experimental | Patients transported by participating EMS units and that were fibrinolytic eligible and treated with a half dose pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase) and randomized to urgent catheterization with percutaneous coronary intervention (PCI). Receives: Drug: Reteplase 10 U; Procedure: Urgent Percutaneous Coronary Intervention (PCI) |
| Group C: Fibrinolytic ineligible patients receiving primary PCI | Active comparator | Patients transported by participating EMS units and that were fibrinolytic ineligible and treated with primary PCI alone and that were prospectively analyzed for comparison. Receives: Procedure: Primary Percutaneous Coronary Intervention (PCI) |
| Group D: Patients transferred in and treated with primary PCI | Active comparator | Patients not transported by participating EMS units but were transferred in and treated with primary PCI alone and that were prospectively analyzed for comparison. Receives: Procedure: Primary Percutaneous Coronary Intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 Days
Measured: 30 day
Secondary outcomes (4)
Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI)
Measured: 1 year
Reduction in Time From Onset of Pain to Reperfusion
Measured: 1 year
Angiographic Documentation of Reperfusion
Measured: 1 year
Electrocardiogram (ECG) ST Segment Elevation Recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Smalling, The University of Texas Health Science Center, Houston
- Investigators
- Richard W. Smalling, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178620
- Sponsor's protocol ID
- PATCAR Pilot Trial HSC 03-021
- Acronym
- PATCAR
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2005
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
- ClinicalTrials.gov ID
- NCT00178620
- Acronym / sponsor ID
- PATCAR / PATCAR Pilot Trial HSC 03-021
- Keywords
- Heart Disease, Heart Attack, Myocardial Infarction, Thrombolytic Therapy, Emergency Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2003 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 6 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500 patients to pre-hospital thrombolysis/clot busting followed by emergent catheterization and stenting of the problematic or culprit artery.
This will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent transportation to a Level I Cardiovascular Center where the patients will be taken to urgent cardiac catheterization and emergent stenting of the culprit artery.
Patients identified as having typical symptoms of acute MI and an ECG consistent with acute ST elevation MI will be screened in the field by paramedics or in the spoke hospitals by the ED attending physicians using the screening form. Verbal Consent will be obtained for receiving acute therapy for their MI as outlined in the protocol. After therapy is initiated in the field or at the spoke hospital, the patients will be transported as quickly as possible to the receiving Level I Cardiovascular Center (Hub Hospital). The ED personnel in the Level I Cardiovascular Center will have activated the Interventional Cardiovascular Team and the Cath Lab personnel after having received the initial qualifying transmitted ECG.
Once the patient arrives, informed consent will be obtained by the ED investigator and/or in-house Cardiology fellow for enrollment in the PATCAR Trial. Thrombolytic ineligible patients will also be collect for this study and also go directly to the Cath Lab for PCI. Study coordinators will enter the data into the Case Report Forms and forward the completed forms to Westat-ALA for data capture in the database. In addition to the qualifying ECG, ECG's will be obtained at hospital discharge/transfer. All patients will follow the current standard of care for STEMI/heart attacks patients. Patients will have a Cardiac MRI done on day 3 or 5 of their hospital stay, to measure the size and amount of damage the heart suffered as a result of their Heart attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Full dose pre-hospital fibrinolysis | Experimental | Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 UPatients transported by participating EMS units and that were fibrinolytic eligible and treated with full dose, pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase and randomized to a second 10-unit dose of reteplase). |
| Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI | Experimental | Drug: Reteplase 10 U, Procedure: Urgent Percutaneous Coronary Intervention (PCI)Patients transported by participating EMS units and that were fibrinolytic eligible and treated with a half dose pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase) and randomized to urgent catheterization with percutaneous coronary intervention (PCI). |
| Group C: Fibrinolytic ineligible patients receiving primary PCI | Active comparator | Procedure: Primary Percutaneous Coronary Intervention (PCI)Patients transported by participating EMS units and that were fibrinolytic ineligible and treated with primary PCI alone and that were prospectively analyzed for comparison. |
| Group D: Patients transferred in and treated with primary PCI | Active comparator | Procedure: Primary Percutaneous Coronary Intervention (PCI)Patients not transported by participating EMS units but were transferred in and treated with primary PCI alone and that were prospectively analyzed for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reteplase 10 Units (U) plus a second dose of reteplase 10 UAlso: RetavaseThrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose | Drug | Group A: Full dose pre-hospital fibrinolysis |
| Reteplase 10 UAlso: RetavaseThrombolytic-clot busting drug Retavase IV Bolus in one 10U dose | Drug | Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI |
| Urgent Percutaneous Coronary Intervention (PCI) | Procedure or surgery | Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI |
| Primary Percutaneous Coronary Intervention (PCI) | Procedure or surgery | Group C: Fibrinolytic ineligible patients receiving primary PCI, Group D: Patients transferred in and treated with primary PCI |
Primary outcome
Mortality at 30 Days
Time frame: 30 day
4 secondary outcomes
Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: 1 year
Reduction in Time From Onset of Pain to Reperfusion
Time frame: 1 year
Angiographic Documentation of Reperfusion
Time frame: 1 year
Electrocardiogram (ECG) ST Segment Elevation Recovery
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W. Smalling, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reteplase 10 Units (U) plus a second dose of reteplase 10 U, Reteplase 10 U and Urgent Percutaneous Coronary Intervention (PCI) in people with Heart Disease and Myocardial Infarction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 4 inclusion and 6 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality at 30 Days (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.