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

September 21, 2013
September 21, 2013
March 2013
December 2014   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis
Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • Experimental: Ticagrelor
    Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge.
    Intervention: 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.
    Intervention: Drug: Clopidogrel 600mg loading dose and 150mg maintenance dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Dimitrios Alexopoulos, Professor 00302610999281 dalex@med.upatras.gr
Greece
 
NCT01950416
PATRASCARDIOLOGY-14
No
Dimitrios Alexopoulos, University of Patras
University of Patras
Not Provided
Not Provided
University of Patras
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP