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Completed

NCT Number: NCT01463163

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)

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.

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Key information

Conditions

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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.
  • Severe uncontrolled chronic obstructive pulmonary disease
  • Known severe hepatic impairement

Treatment and study plan

Prasugrel

Drug

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

Ticagrelor

Drug

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

Primary outcomes

  1. Platelet reactivity

    Time frame: 1hour

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

Secondary outcomes

  1. Platelet reactivity

    Time frame: 1 hour

    Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization

  2. Platelet reactivity

    Time frame: 2 hours

    Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization

  3. Platelet reactivity

    Time frame: 2 hours

    Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization

  4. Platelet reactivity

    Time frame: 6 hours

    Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization

  5. Platelet reactivity

    Time frame: 6 hours

    Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization

  6. Platelet reactivity

    Time frame: 24 hours

    Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization

  7. Platelet reactivity

    Time frame: 24 hours

    Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization

  8. Platelet reactivity

    Time frame: 5 days

    Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization

  9. Platelet reactivity

    Time frame: 5 days

    Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2011
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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