ST Elevation Myocardial Infarction Clinical Trial
— TASTEROfficial title:
Ticagrelor Administered as Standard Tablet or orodispersiblE foRmulation
Verified date | August 2021 |
Source | Azienda Ospedaliero Universitaria di Sassari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized clinical study evaluating superiority in platelet inhibition after administration of Ticagrelor 180 mg loading dose as an orodispersible formulation versus traditional coated tablets in patients admitted for ST elevation myocardial infarction or very high-risk non-ST elevation myocardial infarction.
Status | Completed |
Enrollment | 130 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients presenting within 12 hours from the onset of symptoms with STEMI or very high-risk NSTEMI referred for immediate (< 2 hours) angiography. Very high-risk NSTEMI patients include patients with haemodynamic instability or cardiogenic shock, heart failure, life-threatening arrhythmias or resuscitated cardiac arrest, intermittent ST-segment elevation, or ongoing chest pain. 2. Informed, written consent 3. Male or female patients, aged = 18 years old Exclusion Criteria: 1. Age < 18 years 2. Active bleeding; bleeding diathesis; coagulopathy 3. History of gastrointestinal or genitourinary bleeding <2 months 4. Major surgery in the last 6 weeks 5. History of intracranial bleeding or structural abnormalities 6. Suspected aortic dissection 7. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux. 8. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic window 9. Known relevant hematological deviations: Hb <10 g/dl, Thromb. <100x10^9/l 10. Use of warfarin or new oral anticoagulant derivatives within the last 7 days 11. Known severe liver disease, severe renal failure 12. Allergy or hypersensitivity to ticagrelor or any of the excipients. 13. Pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
Italy | Cardiologia Clinica e Interventistica - AOU Sassari | Sassari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria di Sassari | AstraZeneca |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Morphine-ticagrelor Interaction | Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use | 6 hours | |
Other | Incidence of Adverse Events Occurring During Hospital Stay | Combined ticagrelor administration-related adverse events defined as in-hospital =2 BARC bleedings, dyspnea, ventricular pauses, allergic reactions, or vomit | Until discharge from the hospital (usually up to 7 days) | |
Primary | Evaluation of Platelet Inhibition | Platelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI.
The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect. |
1 hour | |
Secondary | Percent of Patients With Insufficient Antiaggregation | The percent of patients with a high residual platelet reactivity (PRU > 208 by VerifyNow test), thus not adequately antiaggregated, 1 hour after Ticagrelor LD. | 1 hour | |
Secondary | Number of Participants With Residual Platelet Reactivity at Various Timepoints | Residual platelet reactivity (PRU) at 2, 4 and 6 hours measured by VerifyNow test to assess antiplatelet effect of P2Y12 inhibitors | 2, 4 and 6 hours | |
Secondary | Number of Participants With Clinically Relevant Bleeding Events | Actionable bleeding events across the two different regimens of Ticagrelor administration, requiring diagnostic studies, hospitalization, or treatment by a health care professional (BARC type 2 or higher) | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05601999 -
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
|
Phase 3 | |
Recruiting |
NCT06147986 -
Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells as an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
|
Phase 2 | |
Not yet recruiting |
NCT05881382 -
Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
|
Phase 3 | |
Enrolling by invitation |
NCT02615015 -
SNPs in the DNase 1 Gene Impair Its Activity and Are Increased in a STE-ACS Patient Cohort Compared to Healthy Controls
|
N/A | |
Recruiting |
NCT05812963 -
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute STEMI
|
N/A | |
Recruiting |
NCT05554588 -
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
|
N/A | |
Recruiting |
NCT05450757 -
Shanghai ST-segment Elevation Myocardial Infarction Cohort
|
||
Active, not recruiting |
NCT03278509 -
Evaluation of Decreased Usage of Betablockers After Myocardial Infarction in the SWEDEHEART Registry (REDUCE-SWEDEHEART)
|
Phase 4 | |
Completed |
NCT03156699 -
The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction
|
||
Not yet recruiting |
NCT03263468 -
Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
|
N/A | |
Not yet recruiting |
NCT03266328 -
Procedure and In-hospital Outcome of Patients Under 40 Years Old Undergoing Primary Percutaneous Coronary Intervention for Acute ST Elevated Myocardial Infarction in Assiut University
|
N/A | |
Enrolling by invitation |
NCT04970238 -
Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction
|
Phase 4 | |
Recruiting |
NCT02557217 -
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
|
Phase 2 | |
Recruiting |
NCT02224534 -
Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction
|
Phase 4 | |
Completed |
NCT01136187 -
Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)
|
N/A | |
Not yet recruiting |
NCT04068116 -
Impact of Ischemic Post-conditioning
|
N/A | |
Not yet recruiting |
NCT04063345 -
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03646357 -
BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function
|
Phase 4 | |
Completed |
NCT03984071 -
The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
|
||
Completed |
NCT03740776 -
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI
|