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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01575795
First received: April 9, 2012
Last updated: April 9, 2013
Last verified: April 2013

April 9, 2012
April 9, 2013
April 2012
February 2013   (final data collection date for primary outcome measure)
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
Same as current
Complete list of historical versions of study NCT01575795 on ClinicalTrials.gov Archive Site
  • 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Occurrence of any 5-day bleeding event (BARC Types 1-5)
  • Occurrence of 5-day MACEs [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Occurrence of 5-day MACEs
Same as current
Not Provided
Not Provided
 
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ST-elevation Myocardial Infarction
  • Drug: Ticagrelor
    Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
  • Drug: Ticagrelor
    Ticagrelor 180mg loading dose 180mg loading dose
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01575795
PATRASCARDIOLOGY-10
No
Dimitrios Alexopoulos, University of Patras
University of Patras
Not Provided
Principal Investigator: Dimitrios Alexopoulos, MD Patras University Hospital
University of Patras
April 2013

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