Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study

NCT01642940 | Completed Phase 4

• 1 other identifier: PATRASCARDIOLOGY-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

  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)

  15 days

Secondary Outcomes (1)

• Hyporesponsiveness rate (PRU≥230) at the end of the 2 treatment periods

  Day 15

Study Arms (2)

Prasugrel

ACTIVE COMPARATOR

Drug: Prasugrel

Ticagrelor

EXPERIMENTAL

Drug: Ticagrelor

Interventions

Prasugrel DRUG

Prasugrel 10mg/day

Prasugrel

Ticagrelor DRUG

Ticagrelor 90mg twice a day

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Cardiology Department Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

Related Publications (1)

• 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.

  PMID: 23491524 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, Director of Cardiology Department

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

GR (1)