Myocardial InfarctionPhase 4ERUPTIONNCT02131220
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
A Phase 4 study testing Prourokinase, Tirofiban and normal saline in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Percutaneous Coronary Intervention, Thrombolytic Therapy
- What is being tested?
- Prourokinase, Tirofiban and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Sep 2017
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST-segment elevation AMI within 12 hours of symptom onset
Who cannot join
- Contraindications to thrombolysis or PCI
- Patients administered a fibrinolytic agent before PCI
- Patients enrolled in clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.
- Being tested
- Prourokinase, Tirofiban, normal saline
- Keywords
- No-Reflow Phenomenon
- Medical subject headings
- Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProurokinaseDrug
Also called Reocmbinant Human Prourokinase for Injection, TIANJIN TASLY PHARMACEUTICAL CO.,LTD
20mg intracoronary bolus infusion using selective catheter during PCI
TirofibanDrug
Also called Grand Pharmr (China) Co. Ltd
10ug/kg intracoronary bolus infusion using selective catheter during PCI
normal salineDrug
intracoronary bolus infusion using selective catheter during PCI
| Study group | Role | What they receive |
|---|---|---|
| Prourokinase | Experimental | Intracoronary bolus infusion of 20mg prourokinase using selective catheter Receives: Drug: Prourokinase |
| Tirofiban | Active comparator | Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg) Receives: Drug: Tirofiban |
| Normal saline | Placebo comparator | Intracoronary saline bolus infusion using selective catheter (20ml) Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
Measured: At the end of Percutaneous Coronary Intervention procedure
Secondary outcomes (5)
ST segment resolution in ECG
Measured: 3 hours post PCI procedure
peak troponin T level
Measured: in the 7 days post PCI procedure
plasma N terminal-proBNP levels
Measured: 1 and 30 days post PCI procedure
infarction area confirmed by SPECT
Measured: 30 days post PCI
incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization
Measured: 30 days post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Junbo, Fudan University
- Investigators
- Junbo Ge, M.D., Principal investigator, Department of Cardiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131220
- Sponsor's protocol ID
- Zhongshan 2012-134
- Acronym
- ERUPTION
- Status last verified
- Aug 2018
- First submitted
- 3 May 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON
- ClinicalTrials.gov ID
- NCT02131220
- Acronym / sponsor ID
- ERUPTION / Zhongshan 2012-134
- Keywords
- No-Reflow Phenomenon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prourokinase | Experimental | Drug: ProurokinaseIntracoronary bolus infusion of 20mg prourokinase using selective catheter |
| Tirofiban | Active comparator | Drug: TirofibanIntracoronary tirofiban bolus infusion using selective catheter (10ug/kg) |
| Normal saline | Placebo comparator | Drug: normal salineIntracoronary saline bolus infusion using selective catheter (20ml) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ST-segment elevation AMI within 12 hours of symptom onset
Key exclusion criteria (3 listed)
- Contraindications to thrombolysis or PCI
- Patients administered a fibrinolytic agent before PCI
- Patients enrolled in clinical trials
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 |
|---|---|---|
| ProurokinaseAlso: Reocmbinant Human Prourokinase for Injection, TIANJIN TASLY PHARMACEUTICAL CO.,LTD20mg intracoronary bolus infusion using selective catheter during PCI | Drug | Prourokinase |
| TirofibanAlso: Grand Pharmr (China) Co. Ltd10ug/kg intracoronary bolus infusion using selective catheter during PCI | Drug | Tirofiban |
| normal salineintracoronary bolus infusion using selective catheter during PCI | Drug | Normal saline |
Primary outcome
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
Time frame: At the end of Percutaneous Coronary Intervention procedure
5 secondary outcomes
ST segment resolution in ECG
Time frame: 3 hours post PCI procedure
peak troponin T level
Time frame: in the 7 days post PCI procedure
plasma N terminal-proBNP levels
Time frame: 1 and 30 days post PCI procedure
infarction area confirmed by SPECT
Time frame: 30 days post PCI
incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization
Time frame: 30 days post PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
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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.
Junbo Ge, M.D. principal investigator
Department of Cardiology, Zhongshan Hospital, Fudan University
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 Prourokinase, Tirofiban and normal saline in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan University at 1 site in China.
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 1 inclusion and 3 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 7 Aug 2018. 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 China. 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. Some participants in this study may receive a placebo. 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?
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?
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC) (time frame: At the end of Percutaneous Coronary Intervention procedure). 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 7 Aug 2018.