Working… Menu

Ticagrelor Versus Prasugrel in Acute Coronary Syndromes After Percutaneous Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360437
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Drug: Prasugrel Drug: Ticagrelor Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Prasugrel Drug: Prasugrel
Prasugrel 10mg/day

Experimental: Ticagrelor Drug: Ticagrelor
Ticagrelor 90mg twice a day

Primary Outcome Measures :
  1. Platelet Reactivity Units (PRU) assessed by VerifyNow (Accumetrics) [ Time Frame: Day 15 ]
    The primary outcome will be assessed 15 days after the onset of each study drug

Secondary Outcome Measures :
  1. Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods [ Time Frame: Day 15 ]
    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360437

Layout table for location information
Cardiology Department Patras University Hospital
Rio, Patras, Greece, 26500
Sponsors and Collaborators
University of Patras
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras Identifier: NCT01360437    
Other Study ID Numbers: PATRASCARDIOLOGY-6
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Dimitrios Alexopoulos, University of Patras:
coronary angioplasty
clopidogrel hyporesponsiveness
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Acute Coronary Syndrome
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs