Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

NCT01575795 | Completed Phase 4

• 1 other identifier: PATRASCARDIOLOGY-10
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital). Patients with ST elevation myocardial infarction (symptom onset \< 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU). Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.

Conditions

ST-elevation Myocardial Infarction

Keywords

Ticagrelor; ST elevation acute myocardial infarction; Platelet reactivity

Outcome Measures

Primary Outcomes (1)

• platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

  platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

  1 hour

Secondary Outcomes (10)

• 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.

  1 hour

• 2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B

  0.5 hour

• Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B

  2 hours

• Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B

  4 hours

• 3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B

  0.5 hour

Study Arms (2)

Ticagrelor 180mg loading dose

ACTIVE COMPARATOR

Ticagrelor 180mg loading dose

Drug: Ticagrelor

Ticagrelor 360mg loading dose

EXPERIMENTAL

Ticagrelor 360mg loading dose

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose

Ticagrelor 360mg loading dose

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 (onset of pain \< 12 hours) with indication for primary PCI
• Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
• 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
• 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)
• Known hypersensitivity to ticagrelor
• History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
• Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
• Any previous history of 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
• Thrombolysis administration

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Dimitrios Alexopoulos, MD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

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: April 9, 2012
• First Posted: April 11, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

GR (1)