ST Elevation Myocardial InfarctionPhase 4NCT03797729
Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
A Phase 4 study testing Tirofiban and Normal saline in people with ST Elevation Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- 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
- 500 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2019to Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;
- ST segment elevated ≥ 0.1mV in adjacent two or more leads;
- Scheduled for primary percutaneous coronary intervention without contraindications;
- Written informed consent is obtained.
Who cannot join
- Life expectancy ≤ 1 year;
- History of cerebral hemorrhage;
- History of stroke in 6 months;
- Active hemorrhage;
- Severe hepatic and renal dysfunction(ALT > 3 folds of upper limit of normal, eGFR < 30ml/min/1.73mm^2 or Scr > 200 mmol/L);
- Known hemorrhagic diseases;
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- Known malignant tumour diseases；
- Active peptic ulcer disease;
- Blood platelet counts < 100×10^9/L;
- Blood hemoglobin < 90g/L;
- Pregnancy or lactation period；
- Take part in other intervention clinical trials；
- Investigators think not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Zhangwei Chen, MD, +86 21 64041990, chen.zhangwei@zs-hospital.sh.cn
Danbo Lu, PhD, +86 21 64041990, lu.danbo@zs-hospital.sh.cn
About this study
Official title: Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Tirofiban, Normal saline
- Keywords
- ST Elevation Myocardial Infarction, Tirofiban, Percutaneous Coronary Intervention
- 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.
TirofibanDrug
Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
Normal salineDrug
Also called Sodium Chloride Injection
Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Not described Receives: Drug: Normal saline |
| Tirofiban | Experimental | Not described Receives: Drug: Tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
TIMI flow grades: grade III.
Measured: Immediately after primary percutaneous coronary intervention.
TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
TIMI myocardial perfusion grades: grade III.
Measured: Immediately after primary percutaneous coronary intervention.
Secondary outcomes (4)
Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
Remedial Tirofiban use during primary percutaneous coronary intervention.
Measured: During the process of primary percutaneous coronary intervention.
ST segment
The sum of the initial ST segment elevation drops 70% or more.
Measured: 90 minutes after primary percutaneous coronary intervention.
Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.
Measured: 7 days after primary percutaneous coronary intervention.
Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
Measured: 30 days after primary percutaneous coronary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start14 May 2019
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juying Qian, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797729
- Sponsor's protocol ID
- TRYIT
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT03797729
- Acronym / sponsor ID
- TRYIT
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST Elevation Myocardial Infarction, Tirofiban, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Jan 2019 (actual)
- 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.
Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal saline |
| Tirofiban | Experimental | Drug: Tirofiban |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;
- ST segment elevated ≥ 0.1mV in adjacent two or more leads;
- Scheduled for primary percutaneous coronary intervention without contraindications;
- Written informed consent is obtained.
Key exclusion criteria (13 listed)
- Life expectancy ≤ 1 year;
- History of cerebral hemorrhage;
- History of stroke in 6 months;
- Active hemorrhage;
- Severe hepatic and renal dysfunction(ALT > 3 folds of upper limit of normal, eGFR < 30ml/min/1.73mm^2 or Scr > 200 mmol/L);
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 |
|---|---|---|
| TirofibanUpon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. | Drug | Tirofiban |
| Normal salineAlso: Sodium Chloride InjectionUpon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. | Drug | Normal saline |
Primary outcome
TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
Time frame: Immediately after primary percutaneous coronary intervention.
TIMI flow grades: grade III.
TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
Time frame: Immediately after primary percutaneous coronary intervention.
TIMI myocardial perfusion grades: grade III.
4 secondary outcomes
Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
Time frame: During the process of primary percutaneous coronary intervention.
ST segment
Time frame: 90 minutes after primary percutaneous coronary intervention.
Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
Time frame: 7 days after primary percutaneous coronary intervention.
Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
Time frame: 30 days after primary percutaneous coronary intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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ST Elevation Myocardial Infarction
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.
Juying Qian, MD study chair
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 Tirofiban and Normal saline in people with ST Elevation Myocardial Infarction, run by Shanghai Zhongshan 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 4 inclusion and 13 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 22 Jan 2020. 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 Zhangwei Chen, MD (+8602164041990 ext. 612747, chen.zhangwei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). (time frame: Immediately after primary percutaneous coronary intervention.). The study lists 2 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 22 Jan 2020.