High Bolus Dose of TirofibanPhase 1/2TISPNCT04111289
Effect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome
A Phase 1/2 study testing -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) in people with High Bolus Dose of Tirofiban, run by Assiut University.
Trial summary
The goal of the study to investigate the impact of upstream HBD of Tirofiban on short outcome of STEMI patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Bolus Dose of Tirofiban
- What is being tested?
- -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 28 Jan 2022
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Acute STEMI patient within 12 hours of chest pain
Who cannot join
- -previous infarction in the same infarct- related artery
- ISR
- Resistent cardiogenic shock
- Known CKD with Cr cl less than 60 ml/min
- Uncontrolled HTN more than 180/110 mmHg
- Suspected aortic dissection
Show all 10Show fewer
- Traumatic or prolonged CPR
- Severe trauma or major surgery within 3 month
- Active peptic ulcer within past 3 month
- Known history of coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
The goal of the study to investigate the impact of upstream HBD of Tirofiban on short outcome of STEMI patient.
Read the detailed description
- Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).1 PPCI restores thrombolysis in myocardial infarction flow 3 (TIMI 3) in over 90% of patients. However ,there remains a small proportion of patients, who continue to exhibit overt impairment of myocardial reperfusion despite successful opening of infarct related epicardiual artery (IRA). This phenomenon is called no-reflow, which is largely because of severe microvascular obstruction (MVO).
- Belonging to the class of glycoprotein IIb/IIIa inhibitors (GPIs), tirofiban, can be useful in primary PCI for acute coronary syndrome (ACS).1,2The administration of tirofiban is an efficacious treatment option to reduce ischemic events in patients with The ACS and/or those undergoing PCI.2,3 In most guidelines, abciximab is recommended as the drug of first choice4 due to the finding that tirofiban is less effective than abciximab in platelet inhibition within 60 min of intravenous administration. However, some recent systemic reviews of randomized trials have not demonstrated obvious difference between smGPIs (eptifibatide or tirofiban) and abciximab in terms of angiographic, electrocardiographic, and clinical outcomes of patients undergoing primary PCI.5,6 Tirofiban may provide similar efficacy with an improved safety profile when compared with abciximab, particularly with a high-dose bolus regimen.7,8 In the new guideline, the recommended class of smGPIs has changed from IIb to IIa, but tirofiban remains with a pre-PCI indication of IIb, B.4 Although early treatment was associated with a significantly better TIMI flow and superior TIMI myocardial perfusion grades (TMPG) in some trials,9,10 no difference in clinical outcome was found between the 2 strategies in later study.11 One potential cost of administration of GPIs could be increased bleeding, although both major bleeding and minor bleeding rate are low in the tirofiban-treated patients..
- Conditions
- High Bolus Dose of Tirofiban
- Being tested
- -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)Drug
- After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion )
- Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
- Randomization will be performed by Microsoft Excel where random order will be generated for the study population
| Study group | Role | What they receive |
|---|---|---|
| Patient received upstream high bolus dose of tirofiban | Active comparator | * After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion )
* Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
* Randomization will be performed by Microsoft Excel where random order will be generated for the study population Receives: Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) |
| Patients did not receive upstream high bolus dose of tirofiban | Active comparator | Patient receive tirofiban downstream selectively according to operator discretion Receives: Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (main):
Angiographic result (TIMI flow \& MB) after PPCI.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion28 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Bolus Dose of TirofibanStudies of the same condition, open and under way.
- More trials run by Assiut 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Qaood Mohammed, Assiut University
- Investigators
- Eman Qaood, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111289
- Sponsor's protocol ID
- Tirofiban in STEMI patient
- Acronym
- TISP
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome
- ClinicalTrials.gov ID
- NCT04111289
- Acronym / sponsor ID
- TISP / Tirofiban in STEMI patient
- Conditions
- High Bolus Dose of Tirofiban
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 28 Jan 2022 (estimated)
- First posted
- 1 Oct 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.
The goal of the study to investigate the impact of upstream HBD of Tirofiban on short outcome of STEMI patient.
Detailed description
- Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).1 PPCI restores thrombolysis in myocardial infarction flow 3 (TIMI 3) in over 90% of patients. However ,there remains a small proportion of patients, who continue to exhibit overt impairment of myocardial reperfusion despite successful opening of infarct related epicardiual artery (IRA). This phenomenon is called no-reflow, which is largely because of severe microvascular obstruction (MVO).
- Belonging to the class of glycoprotein IIb/IIIa inhibitors (GPIs), tirofiban, can be useful in primary PCI for acute coronary syndrome (ACS).1,2The administration of tirofiban is an efficacious treatment option to reduce ischemic events in patients with The ACS and/or those undergoing PCI.2,3 In most guidelines, abciximab is recommended as the drug of first choice4 due to the finding that tirofiban is less effective than abciximab in platelet inhibition within 60 min of intravenous administration. However, some recent systemic reviews of randomized trials have not demonstrated obvious difference between smGPIs (eptifibatide or tirofiban) and abciximab in terms of angiographic, electrocardiographic, and clinical outcomes of patients undergoing primary PCI.5,6 Tirofiban may provide similar efficacy with an improved safety profile when compared with abciximab, particularly with a high-dose bolus regimen.7,8 In the new guideline, the recommended class of smGPIs has changed from IIb to IIa, but tirofiban remains with a pre-PCI indication of IIb, B.4 Although early treatment was associated with a significantly better TIMI flow and superior TIMI myocardial perfusion grades (TMPG) in some trials,9,10 no difference in clinical outcome was found between the 2 strategies in later study.11 One potential cost of administration of GPIs could be increased bleeding, although both major bleeding and minor bleeding rate are low in the tirofiban-treated patients..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient received upstream high bolus dose of tirofiban | Active comparator | Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)* After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion ) * Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) * Randomization will be performed by Microsoft Excel where random order will be generated for the study population |
| Patients did not receive upstream high bolus dose of tirofiban | Active comparator | Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)Patient receive tirofiban downstream selectively according to operator discretion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- - Acute STEMI patient within 12 hours of chest pain
Key exclusion criteria (10 listed)
- -previous infarction in the same infarct- related artery
- ISR
- Resistent cardiogenic shock
- Known CKD with Cr cl less than 60 ml/min
- Uncontrolled HTN more than 180/110 mmHg
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 (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)* After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion ) * Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) * Randomization will be performed by Microsoft Excel where random order will be generated for the study population | Drug | Patient received upstream high bolus dose of tirofiban, Patients did not receive upstream high bolus dose of tirofiban |
Primary outcome
Primary (main):
Time frame: 40 days
Angiographic result (TIMI flow \& MB) after PPCI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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.
Eman Qaood principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) in people with High Bolus Dose of Tirofiban, run by Assiut University.
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 1 inclusion and 10 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Doaa Ahmed Fouad, Professor (01001085828, fouaddoaa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (main): (time frame: 40 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 1 Oct 2019.