Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study

University of Patras

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Acute Coronary Syndrome

Treatments

Drug: Prasugrel

Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Identifiers

NCT01642940

PATRASCARDIOLOGY-11

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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