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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Patras
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01950416
First received: September 21, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
ST Elevation Myocardial Infarction
Fibrinolysis
P2Y12 Inhibitor
Drug: Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Drug: Clopidogrel 600mg loading dose and 150mg maintenance dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet reactivity at 2 hours post randomization between the 2 treatment arms [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Platelet reactivity pre-discharge between the 2 treatment arms [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 2 hours post randomization [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 24 hours post randomization [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • High on treatment platelet reactivity (HPR) rates (≥208 PRU) pre discharge [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge.
Drug: Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Active Comparator: Clopidogrel
Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge.
Drug: Clopidogrel 600mg loading dose and 150mg maintenance dose

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950416

Contacts
Contact: Dimitrios Alexopoulos, Professor 00302610999281 dalex@med.upatras.gr

Locations
Greece
Konstantopoulio General Hospital of Athens Recruiting
Athens, Attiki, Greece, 14233
Contact: Sotirios Patsilinakos, MD         
Principal Investigator: Sotirios Patsilinakos, MD         
Patras University Hospital Recruiting
Patras, Greece, 26500
Contact: Dimitrios Alexopoulos, Professor    00302610999281    dalex@med.upatras.gr   
Principal Investigator: Dimitrios Alexopoulos, Professor         
Sponsors and Collaborators
University of Patras
  More Information

No publications provided

Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01950416     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-14
Study First Received: September 21, 2013
Last Updated: September 21, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
ST elevation myocardial infarction
Fibrinolysis
Ticagrelor
Clopidogrel
Platelet reactivity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Clopidogrel
Ticagrelor
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014