Myocardial InfarctionSUIT-AMINCT01181388
Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients
A study testing administration of tirofiban by thrombus aspiration catheter in infarct-related artery and administration of tirofiban by guide catheter in people with Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- administration of tirofiban by thrombus aspiration catheter in infarct-related artery and administration of tirofiban by guide catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Oct 2012
- Phase
- Interventional
- 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
- STEMI patients
- chest pain for less than 12hr
- plan to PCI
Who cannot join
- LM lesion
- stent thrombosis
- cardiac shock
- thrombocytopenia
- allergy to asprin
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 28th division, Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Shaoping Shaoping, MD. PhD, +861064456995, wang_shaoping@hotmail.com
Yunpeng Chi, MD, +861064456541, chiyunpeng0711@sohu.com
About this study
Official title: Impacts of Superselective Infarct-related Artery Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in ST Segment Elevation Myocardial Infarction (STEMI) Patients
Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.
- Conditions
- Myocardial Infarction
- Being tested
- administration of tirofiban by thrombus aspiration catheter in infarct-related artery, administration of tirofiban by guide catheter
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of tirofiban by thrombus aspiration catheter in infarct-related arteryProcedure or surgery
a bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI
administration of tirofiban by guide catheterProcedure or surgery
a bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI
| Study group | Role | What they receive |
|---|---|---|
| intra-guide-catheter infusion of tirofiban | Active comparator | Not described Receives: Procedure: administration of tirofiban by guide catheter |
| intra-thrombus-aspiration-catheter infusion of tirofiban | Experimental | Not described Receives: Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Infarct size, reinfarction, motality, et.al.
Measured: 1 month after PCI
Major adverse cardiovascular events
Infarct size, reinfarction, motality, et.al.
Measured: 3 months after PCI
Major Adverse Cardiovascular Events
Infarct size, reinfarction, motality, et.al.
Measured: 6 months after PCI
Secondary outcomes (1)
number of participants with bleeding events
bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionOct 2012 (estimated)
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 Beijing Anzhen HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181388
- Sponsor's protocol ID
- 64456541
- Acronym
- SUIT-AMI
- Status last verified
- Jun 2010
- First submitted
- 11 Aug 2010
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Superselective Infarct-related Artery Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in ST Segment Elevation Myocardial Infarction (STEMI) Patients
- ClinicalTrials.gov ID
- NCT01181388
- Acronym / sponsor ID
- SUIT-AMI / 64456541
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 13 Aug 2010 (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.
Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-guide-catheter infusion of tirofiban | Active comparator | Procedure: administration of tirofiban by guide catheter |
| intra-thrombus-aspiration-catheter infusion of tirofiban | Experimental | Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI patients
- chest pain for less than 12hr
- plan to PCI
Key exclusion criteria (5 listed)
- LM lesion
- stent thrombosis
- cardiac shock
- thrombocytopenia
- allergy to asprin
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 |
|---|---|---|
| administration of tirofiban by thrombus aspiration catheter in infarct-related arterya bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI | Procedure or surgery | intra-thrombus-aspiration-catheter infusion of tirofiban |
| administration of tirofiban by guide cathetera bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI | Procedure or surgery | intra-guide-catheter infusion of tirofiban |
Primary outcome
Major adverse cardiovascular events
Time frame: 1 month after PCI
Infarct size, reinfarction, motality, et.al.
Major adverse cardiovascular events
Time frame: 3 months after PCI
Infarct size, reinfarction, motality, et.al.
Major Adverse Cardiovascular Events
Time frame: 6 months after PCI
Infarct size, reinfarction, motality, et.al.
1 secondary outcome
number of participants with bleeding events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of tirofiban by thrombus aspiration catheter in infarct-related artery and administration of tirofiban by guide catheter in people with Myocardial Infarction, run by Beijing Anzhen Hospital 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 3 inclusion and 5 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 13 Aug 2010. 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.
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 Shaoping Wang, MD, PhD (+861064456995, wang_shaoping@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 1 month after PCI). The study lists 3 primary outcomes in all. 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 13 Aug 2010.