Myocardial InfarctionNCT04267224
Early Versus Late Loading of Ticagrelol in Patients With STEMI
An observational study of Myocardial Infarction, run by Assiut University.
Trial summary
Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Ticagrelor 90mg
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Apr 2021
- Phase
- Observational
- 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
Study population: The study will include 800 patients (divided in 2 groups), 400 patients receiving the loading dose early more than 60 minutes before the procedure and 400 patients receiving the loading dose in late less than 60 minutes before the procedure.
Who may be able to join
- Patients who were diagnosed as STEMI according to criteria developed by the European Society of Cardiology.
- Onset of maximal intensity of chest pain within 12 hours before procedure.
Who cannot join
- Contraindication to Ticagrelor (e.g., hypersensitivity, active bleeding, history of previous intracranial hemorrage, moderate to severe hepatic impairment, GI bleeding within the past 6 months, major surgery within past 4 weeks)
- Patient who has recently received loading dose of Clopidogrel or are on chronic treatment of Clopidogrel.
- Patients who are on oral anticoagulation therapy that cannot be stopped (i.e., patient with prosthetic valves, chronic AF…etc)
- Patients with clinically significant thrombocytopenia.
- Previous enrolment in the present study (Upstream use of GPIIb/IIIa is not recommended as a concomitant treatment)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Early Versus Late Loading Dose of Ticagrelol in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) . In STEMI patients, PCI is advised in all patients in the first 12 hours after onset of symptoms, the earlier the better.
This condition is referred to as "no-reflow phenomenon." , no-reflow is defined as suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction.
Read more
Effective antiplatelet therapy combining the inhibition of both thromboxane A2-dependent platelet aggregation and P2Y12 receptors is necessary in patients undergoing percutaneous coronary intervention (PCI), particularly those with ST-segment elevation myocardial infarction (STEMI).
The goal of DAPT (Aspirin and P2Y12 receptor inhibitors) is to reduce the risk of ischemic events such as (re)-infarction and the risk of stent thrombosis after PCI. It is logical to assume that early administration of a P2Y12 inhibitor prior to PCI (referred to as pre-treatment) should provide greater benefit given the fact that even the fastest acting oral P2Y12 inhibitors take at least 30-60 min.
Various studies and meta-analyses suggested that pretreatment with Clopidogrel in patients with STEMI could reduce the rate of ischemic events without excess bleeding, but its effectiveness may be limited by its slow onset of action and the variable response. In contrast, the new oral P2Y12-receptor antagonists (Prasugrel or Ticagrelol) inhibit platelet function in less than 1 hour, which is compatible with transfer times for primary PCI.
Ticagrelor is a direct-acting inhibitor of the platelet P2Y12 receptor with a rapid antiplatelet effect. It has been shown to reduce the rate of major cardiovascular events among patients with acute coronary syndromes, as compared with Clopidogrel, and has the potential to improve coronary reperfusion and the prognosis for patients with STEMI treated with primary PCI. but The issue of pre-treatment with ticagrelor for patients with STEMI remains an area of ongoing debate; whether they are initiated in the pre-hospital setting, emergency department, or anywhere .
- Conditions
- Myocardial Infarction
- Being tested
- Ticagrelor 90mg
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
Also called Early versus late loading with Ticagrelol
Ticagrelor is a direct-acting inhibitor of the platelet P2Y12 receptor with a rapid antiplatelet effect. It has been shown to reduce the rate of major cardiovascular events among patients with acute coronary syndromes, as compared with Clopidogrel, and has the potential to improve coronary reperfusion and the prognosis for patients with STEMI treated with primary PCI.
| Study group | Role | What they receive |
|---|---|---|
| Early group | Patients receiving the loading dose of Ticagrelol 90 mg more than 60 minutes before PCI. Receives: Drug: Ticagrelor 90mg | |
| Late group | Patients receiving the loading dose of Ticagrelol 90 mg less than 60 minutes before PCI. Receives: Drug: Ticagrelor 90mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Major adverse cardiovascular events (MACE)
Efficacy end point
Measured: 6 weeks
The occurrence of major or minor bleeding
safety endpoints
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Rayek Maher, Assiut University
- Investigators
- Hany R. Maher, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267224
- Sponsor's protocol ID
- Ticagrelor in STEMI patients
- Status last verified
- Feb 2020
- First submitted
- 25 Sep 2019
- Last updated
- 12 Feb 2020
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Versus Late Loading Dose of Ticagrelol in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04267224
- Acronym / sponsor ID
- Ticagrelor in STEMI patients
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 12 Feb 2020 (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.
Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) . In STEMI patients, PCI is advised in all patients in the first 12 hours after onset of symptoms, the earlier the better.
This condition is referred to as "no-reflow phenomenon." , no-reflow is defined as suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction.
Effective antiplatelet therapy combining the inhibition of both thromboxane A2-dependent platelet aggregation and P2Y12 receptors is necessary in patients undergoing percutaneous coronary intervention (PCI), particularly those with ST-segment elevation myocardial infarction (STEMI).
The goal of DAPT (Aspirin and P2Y12 receptor inhibitors) is to reduce the risk of ischemic events such as (re)-infarction and the risk of stent thrombosis after PCI. It is logical to assume that early administration of a P2Y12 inhibitor prior to PCI (referred to as pre-treatment) should provide greater benefit given the fact that even the fastest acting oral P2Y12 inhibitors take at least 30-60 min.
Various studies and meta-analyses suggested that pretreatment with Clopidogrel in patients with STEMI could reduce the rate of ischemic events without excess bleeding, but its effectiveness may be limited by its slow onset of action and the variable response. In contrast, the new oral P2Y12-receptor antagonists (Prasugrel or Ticagrelol) inhibit platelet function in less than 1 hour, which is compatible with transfer times for primary PCI.
Ticagrelor is a direct-acting inhibitor of the platelet P2Y12 receptor with a rapid antiplatelet effect. It has been shown to reduce the rate of major cardiovascular events among patients with acute coronary syndromes, as compared with Clopidogrel, and has the potential to improve coronary reperfusion and the prognosis for patients with STEMI treated with primary PCI. but The issue of pre-treatment with ticagrelor for patients with STEMI remains an area of ongoing debate; whether they are initiated in the pre-hospital setting, emergency department, or anywhere .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early group | – | Drug: Ticagrelor 90mgPatients receiving the loading dose of Ticagrelol 90 mg more than 60 minutes before PCI. |
| Late group | – | Drug: Ticagrelor 90mgPatients receiving the loading dose of Ticagrelol 90 mg less than 60 minutes before PCI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include 800 patients (divided in 2 groups), 400 patients receiving the loading dose early more than 60 minutes before the procedure and 400 patients receiving the loading dose in late less than 60 minutes before the procedure.
Key inclusion criteria (2 listed)
- Patients who were diagnosed as STEMI according to criteria developed by the European Society of Cardiology.
- Onset of maximal intensity of chest pain within 12 hours before procedure.
Key exclusion criteria (5 listed)
- Contraindication to Ticagrelor (e.g., hypersensitivity, active bleeding, history of previous intracranial hemorrage, moderate to severe hepatic impairment, GI bleeding within the past 6 months, major surgery within past 4 weeks)
- Patient who has recently received loading dose of Clopidogrel or are on chronic treatment of Clopidogrel.
- Patients who are on oral anticoagulation therapy that cannot be stopped (i.e., patient with prosthetic valves, chronic AF…etc)
- Patients with clinically significant thrombocytopenia.
- Previous enrolment in the present study (Upstream use of GPIIb/IIIa is not recommended as a concomitant 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 |
|---|---|---|
| Ticagrelor 90mgAlso: Early versus late loading with TicagrelolTicagrelor is a direct-acting inhibitor of the platelet P2Y12 receptor with a rapid antiplatelet effect. It has been shown to reduce the rate of major cardiovascular events among patients with acute coronary syndromes, as compared with Clopidogrel, and has the potential to improve coronary reperfusion and the prognosis for patients with STEMI treated with primary PCI. | Drug | Early group, Late group |
Primary outcome
The incidence of Major adverse cardiovascular events (MACE)
Time frame: 6 weeks
Efficacy end point
The occurrence of major or minor bleeding
Time frame: 6 weeks
safety endpoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute 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.
Hany R. Maher principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, 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 2 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 12 Feb 2020. 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.
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 Hany R. Maher, Resident (+201221842617, Hanyrayek5287@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Major adverse cardiovascular events (MACE) (time frame: 6 weeks). 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 12 Feb 2020.