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Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis

Primary Purpose

ST Elevation Myocardial Infarction, Fibrinolysis, P2Y12 Inhibitor

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Clopidogrel 600mg loading dose and 150mg maintenance dose
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST elevation myocardial infarction, Fibrinolysis, Ticagrelor, Clopidogrel, Platelet reactivity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-85 years old
  2. Patients with STEMI, having undergone fibrinolytic therapy in the previous 3 to 48 hours
  3. Presenting HPR (≥208 PRU) post 300mg clopidogrel loading dose ( assessment immediately before coronary angiography)
  4. Informed consent obtained in writing

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent
  • Cardiogenic shock
  • Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding)
  • Known hypersensitivity to ticagrelor or clopidogrel
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
  • Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thombocytopenia (<100.000 / μL) at randomization
  • Anaemia (Hct <30%) at randomization
  • Polycytaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitors administration
  • Per os anticoagulants
  • Recent (< 6 weeks) major surgery or trauma, including GABG.
  • Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  • Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
  • Increased risk of bradycardiac events.
  • Dialysis required.
  • Severe uncontrolled chronic obstructive pulmonary disease
  • Known severe hepatic impairement

Sites / Locations

  • Konstantopoulio General Hospital of Athens
  • Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge.

Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge.

Outcomes

Primary Outcome Measures

Platelet reactivity at 2 hours post randomization between the 2 treatment arms
Platelet reactivity at 2 hours post randomization between the 2 treatment arms

Secondary Outcome Measures

Platelet reactivity at 24 hours post randomization between the 2 treatment arms.
Platelet reactivity pre-discharge between the 2 treatment arms
High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 2 hours post randomization
High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 24 hours post randomization
High on treatment platelet reactivity (HPR) rates (≥208 PRU) pre discharge

Full Information

First Posted
September 21, 2013
Last Updated
August 19, 2015
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01950416
Brief Title
Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis
Official Title
Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a two-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers (Patras University Hospital and Konstantopoulio General Hospital of Athens). Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission, pre coronary angiography, will be randomized after written informed consent, in a 1:1 ratio to either: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge. Or Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge. Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24 hours after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet reactivity units (PRU). Documentation of major adverse cardiac events (death, myocardial infarction, stroke, ischemia driven revascularization procedure with PCI or CABG) and bleeding (according to BARC criteria) will be performed until patient's discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Fibrinolysis, P2Y12 Inhibitor
Keywords
ST elevation myocardial infarction, Fibrinolysis, Ticagrelor, Clopidogrel, Platelet reactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge.
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 600mg loading dose and 150mg maintenance dose
Primary Outcome Measure Information:
Title
Platelet reactivity at 2 hours post randomization between the 2 treatment arms
Description
Platelet reactivity at 2 hours post randomization between the 2 treatment arms
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Platelet reactivity at 24 hours post randomization between the 2 treatment arms.
Time Frame
24 hours
Title
Platelet reactivity pre-discharge between the 2 treatment arms
Time Frame
5 days
Title
High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 2 hours post randomization
Time Frame
2 hours
Title
High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 24 hours post randomization
Time Frame
24 hours
Title
High on treatment platelet reactivity (HPR) rates (≥208 PRU) pre discharge
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-85 years old Patients with STEMI, having undergone fibrinolytic therapy in the previous 3 to 48 hours Presenting HPR (≥208 PRU) post 300mg clopidogrel loading dose ( assessment immediately before coronary angiography) Informed consent obtained in writing Exclusion Criteria: Pregnancy Breastfeeding Inability to give informed consent Cardiogenic shock Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding) Known hypersensitivity to ticagrelor or clopidogrel History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). Thombocytopenia (<100.000 / μL) at randomization Anaemia (Hct <30%) at randomization Polycytaemia (Hct > 52%) at randomization Periprocedural IIb/IIIa inhibitors administration Per os anticoagulants Recent (< 6 weeks) major surgery or trauma, including GABG. Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study. Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine). Increased risk of bradycardiac events. Dialysis required. Severe uncontrolled chronic obstructive pulmonary disease Known severe hepatic impairement
Facility Information:
Facility Name
Konstantopoulio General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
14233
Country
Greece
Facility Name
Patras University Hospital
City
Patras
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

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Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis

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