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
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