Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis

NCT01950416 | Completed Phase 4

• 1 other identifier: PATRASCARDIOLOGY-14
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers (Patras University Hospital and Konstantopoulio General Hospital of Athens). Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission, pre coronary angiography, will be randomized after written 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, until discharge. Or Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge. Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24 hours after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet reactivity units (PRU). Documentation of major adverse cardiac events (death, myocardial infarction, stroke, ischemia driven revascularization procedure with PCI or CABG) and bleeding (according to BARC criteria) will be performed until patient's discharge.

Conditions

ST Elevation Myocardial Infarction; Fibrinolysis; P2Y12 Inhibitor

Keywords

ST elevation myocardial infarction; Fibrinolysis; Ticagrelor; Clopidogrel; Platelet reactivity

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity at 2 hours post randomization between the 2 treatment arms

  Platelet reactivity at 2 hours post randomization between the 2 treatment arms

  2 hours

Secondary Outcomes (5)

• Platelet reactivity at 24 hours post randomization between the 2 treatment arms.

  24 hours

• Platelet reactivity pre-discharge between the 2 treatment arms

  5 days

• High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 2 hours post randomization

  2 hours

• High on treatment platelet reactivity (HPR) rate (≥208 PRU) at 24 hours post randomization

  24 hours

• High on treatment platelet reactivity (HPR) rates (≥208 PRU) pre discharge

  5 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD, until discharge.

Drug: Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD) starting 12±6 hours post LD, until discharge.

Drug: Clopidogrel 600mg loading dose and 150mg maintenance dose

Interventions

Ticagrelor 180mg loading dose and 90mg bid maintenance dose DRUG

Ticagrelor

Clopidogrel 600mg loading dose and 150mg maintenance dose DRUG

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years old
• Patients with STEMI, having undergone fibrinolytic therapy in the previous 3 to 48 hours
• Presenting HPR (≥208 PRU) post 300mg clopidogrel loading dose ( assessment immediately before coronary angiography)
• Informed consent obtained in writing

You may not qualify if:

• Pregnancy
• Breastfeeding
• Inability to give informed consent
• 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)
• Known hypersensitivity to ticagrelor or clopidogrel
• 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).
• Thombocytopenia (\<100.000 / μL) at randomization
• Anaemia (Hct \<30%) at randomization
• Polycytaemia (Hct \> 52%) at randomization
• Periprocedural IIb/IIIa inhibitors administration
• Per os anticoagulants
• Recent (\< 6 weeks) major surgery or trauma, including GABG.

Sponsors & Collaborators

• University of Patras: lead

Study Sites (2)

Konstantopoulio General Hospital of Athens

Athens, Attica, 14233, Greece

Location

Patras University Hospital

Pátrai, 26500, Greece

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ticagrelor; Clopidogrel

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; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

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: September 21, 2013
• First Posted: September 25, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

GR (2)