- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267224
Early Versus Late Loading of Ticagrelol in Patients With STEMI
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.
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 Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hany R. Maher, Resident
- Phone Number: +201221842617
- Email: Hanyrayek5287@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early group
Patients receiving the loading dose of Ticagrelol 90 mg more than 60 minutes before 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.
Other Names:
|
Late group
Patients receiving the loading dose of Ticagrelol 90 mg less than 60 minutes before 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of Major adverse cardiovascular events (MACE)
Time Frame: 6 weeks
|
Efficacy end point
|
6 weeks
|
The occurrence of major or minor bleeding
Time Frame: 6 weeks
|
safety endpoints
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hany R. Maher, Assiut University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- Ticagrelor in STEMI patients
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Ticagrelor 90mg
-
Cairo UniversityCompletedCardiovascular Diseases | Acute Coronary SyndromeEgypt
-
Dong-A UniversityRecruitingAcute Myocardial InfarctionKorea, Republic of
-
Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
-
Beijing Anzhen HospitalUnknownCoronary Artery Disease | Percutaneous Coronary Intervention | Antiplatelet TherapyChina
-
University of FloridaThe Medicines CompanyCompletedCoronary Artery DiseaseUnited States
-
University of FloridaAstraZenecaCompleted
-
Vastra Gotaland RegionSahlgrenska University Hospital, SwedenRecruiting
-
Shanghai Tong Ren HospitalFudan University; Shanghai Jiao Tong University School of MedicineRecruitingAcute Coronary Syndrome | Coronary Stent ImplantationChina
-
Brigham and Women's HospitalCompleted
-
Cairo UniversityCompleted