Ticagrelor Versus Prasugrel in Acute Coronary Syndromes After Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01360437
First received: May 23, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

This is a single-center, randomized, single-blind, investigator-initiated pharmacological study with a crossover design. Patients with acute coronary syndrome (ST-elevation myocardial infarction, non-ST elevation myocardial infarction, unstable angina) and presenting high on-clopidogrel platelet reactivity as assessed with the VerifyNow assay (platelet reactivity units PRU≥235) 24 hours post percutaneous coronary intervention (PCI), will be randomized after informed consent in a 1:1 ratio to either prasugrel 10mg/d or ticagrelor 90mg twice a day for 15 days. Platelet reactivity assessment will be performed at Day 15±2 days and then a crossover directly to the alternate treatment group for an additional 15 days period, without an intervening washout period will be carried out. Patients will return at Day 30±2 days for platelet reactivity assessment.


Condition Intervention Phase
Coronary Artery Disease
Acute Coronary Syndrome
Drug: Prasugrel
Drug: Ticagrelor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ticagrelor in Comparison to Prasugrel for Inhibition of Platelet Reactivity, in Patients With Acute Coronary Syndrome (ACS) Presenting Resistance to the Usual Clopidogrel Dose After PCI

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet Reactivity Units (PRU) assessed by VerifyNow (Accumetrics) [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    The primary outcome will be assessed 15 days after the onset of each study drug


Secondary Outcome Measures:
  • Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug


Enrollment: 44
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel Drug: Prasugrel
Prasugrel 10mg/day
Experimental: Ticagrelor Drug: Ticagrelor
Ticagrelor 90mg twice a day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients having PCI with stenting 24 hours prior randomization, meeting one of the following criteria :

    • Acute coronary syndrome (unstable angina or myocardial infarction)
    • TIMI risk score>2
  3. Platelet reactivity in PRU ≥235 24 hours post-PCI
  4. Informed consent obtained in writing

Exclusion Criteria:

  • Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
  • 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 (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), 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 30 days after randomization
  • Requirement for oral anticoagulant prior to the Day 30 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 on longterm thienopyridine therapy.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360437

Locations
Greece
Cardiology Department Patras University Hospital
Rio, Patras, 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: NCT01360437     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-6
Study First Received: May 23, 2011
Last Updated: June 21, 2012
Health Authority: Greece: Ethics Commitee

Keywords provided by University of Patras:
coronary angioplasty
clopidogrel hyporesponsiveness
prasugrel
ticagrelor
CAD
ACS

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Prasugrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014