Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01463163
First received: October 27, 2011
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:

Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).

Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.


Condition Intervention Phase
Platelet Reactivity
Drug: Prasugrel
Drug: Ticagrelor
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: Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet reactivity [ Time Frame: 1hour ] [ Designated as safety issue: No ]
    Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization


Secondary Outcome Measures:
  • Platelet reactivity [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization

  • Platelet reactivity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization

  • Platelet reactivity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization

  • Platelet reactivity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization

  • Platelet reactivity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization

  • Platelet reactivity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization

  • Platelet reactivity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization

  • Platelet reactivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization

  • Platelet reactivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel
Prasugrel 60mg LD followed by 10mg MD starting post 24 hours
Drug: Prasugrel
Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
Experimental: Ticagrelor
Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours
Drug: Ticagrelor
Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients with STEMI undergoing primary PCI with stenting
  3. Informed consent obtained in writing

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent or high likelihood of being unavailable until the Day 5
  • Prior PCI performed within 30 days prior to randomization
  • 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).
  • Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
  • Requirement for oral anticoagulant prior to the Day 5 visit
  • Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
  • Known hypersensitivity to prasugrel or ticagrelor
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding.
  • Any previous history of ischemic 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
  • Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
  • 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: NCT01463163

Locations
Greece
Cardiology Department Patras University Hospital
Rio, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras
  More Information

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01463163     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-8
Study First Received: October 27, 2011
Last Updated: April 9, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Platelet reactivity
Ticagrelor
Prasugrel

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Prasugrel
Ticagrelor
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 23, 2014