Coronary Artery DiseasePhase 4NCT02294994
Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
A Phase 4 study testing tirofiban in people with Coronary Artery Disease, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score>26,chronic total occlusion… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent
- Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI
- Experienced ischaemic pain at rest
- Lasting 10 minutes and occurring within 7 days before enrollment
- As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -
- High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score > 26 and chronic total occlusion disease.
Who cannot join
- Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
- Recent (<1 month) trauma or major surgery (including bypass surgery);
- Active bleeding
- Unexplained clinically significant bleeding, thrombocytopenia (platelet count < 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy
- Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure > 180 mm Hg despite treatment)
- Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours
- Receiving antiIIb/IIIa therapy
- Creatinine clearance of <30 mL/min
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The sencond hospital of Jilin University
Changchun, Jilin, 130041
Liu Bin, M.D., +86 13500810268, liubin3333@vip.sina.com
About this study
Official title: Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.
- Conditions
- Coronary Artery Disease
- Being tested
- tirofiban
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofibanDrug
Also called GPIIb/IIIa inhibitor, aggrastat
| Study group | Role | What they receive |
|---|---|---|
| half dose tirofiban | Experimental | Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI. Receives: Drug: tirofiban |
| recommended-dose Tirofiban | Active comparator | Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI. Receives: Drug: tirofiban |
| none tirofiban | Placebo comparator | Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI. Receives: Drug: tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Events
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Measured: 30 days
Secondary outcomes (4)
Net adverse clinical events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
Measured: 1 year
any bleedings (BARC class)
including all BARC class (class 1-5)
Measured: 30 days
Major adverse cardiac and cerebral events (MACCE)
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Measured: 30 days and 1 year
stent thrombosis
by ARC definition
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Bin, M.D., Principal investigator, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294994
- Sponsor's protocol ID
- SecondJilinU-1
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02294994
- Acronym / sponsor ID
- SecondJilinU-1
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Nov 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 aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| half dose tirofiban | Experimental | Drug: tirofibanTirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI. |
| recommended-dose Tirofiban | Active comparator | Drug: tirofibanTirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI. |
| none tirofiban | Placebo comparator | Drug: tirofibanTirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent
- Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI
- Experienced ischaemic pain at rest
- Lasting 10 minutes and occurring within 7 days before enrollment
- As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -
Key exclusion criteria (8 listed)
- Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
- Recent (<1 month) trauma or major surgery (including bypass surgery);
- Active bleeding
- Unexplained clinically significant bleeding, thrombocytopenia (platelet count < 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy
- Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure > 180 mm Hg despite treatment)
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 |
|---|---|---|
| tirofibanAlso: GPIIb/IIIa inhibitor, aggrastat | Drug | half dose tirofiban, none tirofiban, recommended-dose Tirofiban |
Primary outcome
Net Adverse Clinical Events
Time frame: 30 days
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
4 secondary outcomes
Net adverse clinical events
Time frame: 1 year
any bleedings (BARC class)
Time frame: 30 days
Major adverse cardiac and cerebral events (MACCE)
Time frame: 30 days and 1 year
stent thrombosis
Time frame: 30 days and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Liu Bin, M.D. principal investigator
Jilin 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 tirofiban in people with Coronary Artery Disease, run by Second Hospital of Jilin 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 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 2 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Bin, M.D. (+86 13500810268, liubin3333@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Adverse Clinical Events (time frame: 30 days). 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 2 Dec 2014.