Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

NCT01463163 | Completed Phase 4

• 1 other identifier: PATRASCARDIOLOGY-8
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization). Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.

Conditions

Platelet Reactivity

Keywords

Platelet reactivity; Ticagrelor; Prasugrel

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

  Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization

  1hour

Secondary Outcomes (9)

• Platelet reactivity

  1 hour

• Platelet reactivity

  2 hours

• Platelet reactivity

  2 hours

• Platelet reactivity

  6 hours

• Platelet reactivity

  6 hours

Study Arms (2)

Prasugrel

ACTIVE COMPARATOR

Prasugrel 60mg LD followed by 10mg MD starting post 24 hours

Drug: Prasugrel

Ticagrelor

EXPERIMENTAL

Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours

Drug: Ticagrelor

Interventions

Prasugrel DRUG

Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours

Prasugrel

Ticagrelor DRUG

Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• Patients with STEMI undergoing primary PCI with stenting
• Informed consent obtained in writing

You may not qualify if:

• Pregnancy
• Breastfeeding
• Inability to give informed consent or high likelihood of being unavailable until the Day 5
• 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 (arteriovenous shunt, retroperitoneal bleeding), 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 5 days after randomization
• Requirement for oral anticoagulant prior to the Day 5 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.
• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Location

Related Publications (1)

• Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20.

  PMID: 23169985 DERIVED

MeSH Terms

Interventions

Prasugrel Hydrochloride; Ticagrelor

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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

GR (1)