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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)

Primary Purpose

ST-elevation Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Ticagrelor

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Ticagrelor, ST elevation acute myocardial infarction, Platelet reactivity

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiology Department Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ticagrelor 180mg loading dose

Ticagrelor 360mg loading dose

Arm Description

Ticagrelor 180mg loading dose

Ticagrelor 360mg loading dose

Outcomes

Primary Outcome Measures

platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

Secondary Outcome Measures

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

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

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

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

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

Occurrence of any 5-day bleeding event (BARC Types 1-5)

Occurrence of 5-day MACEs

Full Information

NCT ID

NCT01575795

First Posted

April 9, 2012

Last Updated

April 9, 2013

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01575795

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST-elevation Myocardial Infarction

Keywords

Ticagrelor, ST elevation acute myocardial infarction, Platelet reactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor 180mg loading dose

Arm Type

Active Comparator

Arm Description

Ticagrelor 180mg loading dose

Arm Title

Ticagrelor 360mg loading dose

Arm Type

Experimental

Arm Description

Ticagrelor 360mg loading dose

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor 180mg loading dose 180mg loading dose

Primary Outcome Measure Information:

Title

platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

Description

platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.

Description

1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.

Time Frame

1 hour

Title

2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B

Description

Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B

Time Frame

0.5 hour

Title

Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B

Description

Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B

Time Frame

2 hours

Title

Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B

Description

Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B

Time Frame

4 hours

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

Occurrence of any 5-day bleeding event (BARC Types 1-5)

Description

Occurrence of any 5-day bleeding event (BARC Types 1-5)

Time Frame

5 days

Title

Occurrence of 5-day MACEs

Description

Occurrence of 5-day MACEs

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dimitrios Alexopoulos, MD

Organizational Affiliation

University Hospital of Patras

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiology Department Patras University Hospital

City

Rio

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

12. IPD Sharing Statement

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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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