Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01642940
First received: July 12, 2012
Last updated: January 21, 2013
Last verified: January 2013

July 12, 2012
January 21, 2013
June 2012
September 2012   (final data collection date for primary outcome measure)
Platelet reactivity [ Time Frame: 15 days ] [ Designated as safety issue: No ]
The primary outcome will be assessed 15 days after the onset of each study drug by the VerifyNow (Accumetrics)assay in platelet reactivity units (PRU)
Same as current
Complete list of historical versions of study NCT01642940 on ClinicalTrials.gov Archive Site
Hyporesponsiveness rate (PRU≥230) 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
Same as current
Not Provided
Not Provided
 
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study

This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the alternate therapy for an additional 15 days without an intervening washout period.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • Drug: Prasugrel
    Prasugrel 10mg/day
  • Drug: Ticagrelor
    Ticagrelor 90mg twice a day
  • Active Comparator: Prasugrel
    Intervention: Drug: Prasugrel
  • Experimental: Ticagrelor
    Intervention: Drug: Ticagrelor
Alexopoulos D, Xanthopoulou I, Mavronasiou E, Stavrou K, Siapika A, Tsoni E, Davlouros P. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with diabetes. Diabetes Care. 2013 Aug;36(8):2211-6. doi: 10.2337/dc12-2510. Epub 2013 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 75 years
  • Diabetic patients treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month
  • Patients with acute coronary syndrome subjected to PCI with a baseline PR evaluation 24 hours post PCI while on clopidogrel
  • 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.
  • 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).
  • Thrombocytopenia (< 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.
  • Age ≥ 75 years
  • Weight < 60 Kg
  • Severe hepatic impairment
  • Severe uncontrolled chronic obstructive pulmonary disease
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01642940
PATRASCARDIOLOGY-11
No
Dimitrios Alexopoulos, University of Patras
University of Patras
Not Provided
Not Provided
University of Patras
January 2013

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