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

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ClinicalTrials.gov Identifier: NCT01575795
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

Tracking Information
First Submitted Date  ICMJE April 9, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date April 10, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms. [ Time Frame: 1 hour ]
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms. [ Time Frame: 1 hour ]
    1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
  • 2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B [ Time Frame: 0.5 hour ]
    Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
  • Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B [ Time Frame: 2 hours ]
    Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
  • Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B [ Time Frame: 4 hours ]
    Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
  • 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 [ Time Frame: 0.5 hour ]
    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
  • High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B [ Time Frame: 1 hour ]
    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
  • High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B [ Time Frame: 2 hours ]
    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
  • High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B [ Time Frame: 4 hours ]
    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
  • Occurrence of any 5-day bleeding event (BARC Types 1-5) [ Time Frame: 5 days ]
    Occurrence of any 5-day bleeding event (BARC Types 1-5)
  • Occurrence of 5-day MACEs [ Time Frame: 5 days ]
    Occurrence of 5-day MACEs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Official Title  ICMJE Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ST-elevation Myocardial Infarction
Intervention  ICMJE
  • Drug: Ticagrelor
    Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
  • Drug: Ticagrelor
    Ticagrelor 180mg loading dose 180mg loading dose
Study Arms  ICMJE
  • Active Comparator: Ticagrelor 180mg loading dose
    Ticagrelor 180mg loading dose
    Intervention: Drug: Ticagrelor
  • Experimental: Ticagrelor 360mg loading dose
    Ticagrelor 360mg loading dose
    Intervention: Drug: Ticagrelor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
130
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Patients with STEMI (onset of pain < 12 hours) with indication for primary PCI
  3. Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
  4. Informed consent obtained in writing

Exclusion Criteria

  • 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
  • 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 impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575795
Other Study ID Numbers  ICMJE PATRASCARDIOLOGY-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dimitrios Alexopoulos, University of Patras
Study Sponsor  ICMJE University of Patras
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dimitrios Alexopoulos, MD University Hospital of Patras
PRS Account University of Patras
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP