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
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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.
Condition or disease | Intervention/treatment | Phase |
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ST-elevation Myocardial Infarction | Drug: Ticagrelor | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
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Active Comparator: Ticagrelor 180mg loading dose
Ticagrelor 180mg loading dose
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Drug: Ticagrelor
Ticagrelor 180mg loading dose 180mg loading dose |
Experimental: Ticagrelor 360mg loading dose
Ticagrelor 360mg loading dose
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Drug: Ticagrelor
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose |
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575795
Greece | |
Cardiology Department Patras University Hospital | |
Rio, Achaia, Greece, 26500 |
Principal Investigator: | Dimitrios Alexopoulos, MD | University Hospital of Patras |
Responsible Party: | Dimitrios Alexopoulos, Professor, University of Patras |
ClinicalTrials.gov Identifier: | NCT01575795 |
Other Study ID Numbers: |
PATRASCARDIOLOGY-10 |
First Posted: | April 11, 2012 Key Record Dates |
Last Update Posted: | April 10, 2013 |
Last Verified: | April 2013 |
Ticagrelor ST elevation acute myocardial infarction Platelet reactivity |
Myocardial Infarction ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Ticagrelor Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |