STEMIPhase 3NCT02367976
Efficacy and Safety on Prouk for STEMI Patients in China
A Phase 3 study testing rhprouk in people with STEMI, run by Suzhou RxD Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- STEMI
- What is being tested?
- rhprouk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 3
- 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
- Chest pain > 30 minutes, while <12 hours
- Expected PCI related delayed time > 60 minutes, OR Door To Balloon time >90 minutes
- ECG confirmed STEMI.
- Age: 18--75 years old
- Weight <=85Kg
- Consent to participate in this study
Who cannot join
- Evidence of cardiac rupture;
- ECG: new left bundle branch block;
- Thrombolysis contradictions
- Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months);
- Active bleeding or known bleeding disorder.
- Recent administration of any i.v. or s.c. anticoagulation within 12 hours includingunfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation(warfarin or coumadin);
- Uncontrolled hypertension, defined as a single blood pressure measurement ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to randomisation;
- Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 Weeks Major surgery pending in the following 30 days;
Trial locations and contacts
1 site in 1 country.
Weiqun Shen, MD/PhD contact
Jing Zhang, PhD contact
China1 site, 1 recruiting
- Recruiting
Shenyang Northern Hospital
Shenyang, Liaoning
Weiqun Shen, MD/PhD, jingzhang@gmail.com
Jing Zhang, PhD, jingzhang@gmail.com
About this study
Official title: A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
Read the detailed description
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
- Conditions
- STEMI
- Being tested
- rhprouk
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhproukDrug
Also called Controlled
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
| Study group | Role | What they receive |
|---|---|---|
| rhprouk | Experimental | rhprouk to be administrated in 60 minutes. Receives: Drug: rhprouk |
| controlled | No intervention | The controlled arm patients will be administrated in 90 minutes after randomized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
Measured: 90 minutes after administrative of active/comparator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou RxD Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiqun Shen, MD/PhD, Study director, Suzhou RxD Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367976
- Sponsor's protocol ID
- 2012L01494
- Status last verified
- Feb 2015
- First submitted
- 15 Jan 2015
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China
- ClinicalTrials.gov ID
- NCT02367976
- Acronym / sponsor ID
- 2012L01494
- Conditions
- STEMI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Suzhou RxD Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Feb 2015 (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 the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
Detailed description
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhprouk | Experimental | Drug: rhproukrhprouk to be administrated in 60 minutes. |
| controlled | No intervention | –The controlled arm patients will be administrated in 90 minutes after randomized. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chest pain > 30 minutes, while <12 hours
- Expected PCI related delayed time > 60 minutes, OR Door To Balloon time >90 minutes
- ECG confirmed STEMI.
- Age: 18--75 years old
- Weight <=85Kg
Key exclusion criteria (8 listed)
- Evidence of cardiac rupture;
- ECG: new left bundle branch block;
- Thrombolysis contradictions
- Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months);
- Active bleeding or known bleeding disorder.
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 |
|---|---|---|
| rhproukAlso: Controlledrh-prouk will be administrated within 60 minutes after the patients eligibility confirmed | Drug | rhprouk |
Primary outcome
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
Time frame: 90 minutes after administrative of active/comparator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
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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.
Weiqun Shen, MD/PhD contact
Jing Zhang, PhD contact
Weiqun Shen, MD/PhD study director
Suzhou RxD Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhprouk in people with STEMI, run by Suzhou RxD Biopharmaceutical Co., Ltd 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiqun Shen, MD/PhD (jingzhang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms (time frame: 90 minutes after administrative of active/comparator). 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 25 Feb 2015.