ST-elevation Myocardial InfarctionPhase 4NCT01575795
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
A Phase 4 study testing Ticagrelor in people with ST-elevation Myocardial Infarction, run by University of Patras at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2012to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiology Department Patras University Hospital
Rio, Achaia, 26500
About this study
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.
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:
Read more
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.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Ticagrelor
- Keywords
- Ticagrelor, ST elevation acute myocardial infarction, Platelet reactivity
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
TicagrelorDrug
Ticagrelor 180mg loading dose 180mg loading dose
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor 180mg loading dose | Active comparator | Ticagrelor 180mg loading dose Receives: Drug: Ticagrelor |
| Ticagrelor 360mg loading dose | Experimental | Ticagrelor 360mg loading dose Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
Measured: 1 hour
Secondary outcomes (10)
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
- Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
Measured: 1 hour
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
Measured: 0.5 hour
Platelet reactivity at 2 hours 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
Measured: 2 hours
Platelet reactivity at 4 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
Measured: 4 hours
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
Measured: 0.5 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 1 hour post randomization between the 2 treatment arms, separately for Group A and B
Measured: 1 hour
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 2 hours post randomization between the 2 treatment arms, separately for Group A and B
Measured: 2 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
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
Measured: 4 hours
Occurrence of any 5-day bleeding event (BARC Types 1-5)
Occurrence of any 5-day bleeding event (BARC Types 1-5)
Measured: 5 days
Occurrence of 5-day MACEs
Occurrence of 5-day MACEs
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
- Investigators
- Dimitrios Alexopoulos, MD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575795
- Sponsor's protocol ID
- PATRASCARDIOLOGY-10
- Status last verified
- Apr 2013
- First submitted
- 9 Apr 2012
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01575795
- Acronym / sponsor ID
- PATRASCARDIOLOGY-10
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- Ticagrelor, ST elevation acute myocardial infarction, Platelet reactivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor 180mg loading dose | Active comparator | Drug: TicagrelorTicagrelor 180mg loading dose |
| Ticagrelor 360mg loading dose | Experimental | Drug: TicagrelorTicagrelor 360mg loading dose |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorTicagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose | Drug | Ticagrelor 360mg loading dose |
| TicagrelorTicagrelor 180mg loading dose 180mg loading dose | Drug | Ticagrelor 180mg loading dose |
Primary outcome
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.
10 secondary outcomes
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
Time frame: 1 hour
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 2 hours post randomization between the 2 treatment arms separately for Group A and B
Time frame: 2 hours
Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
Time frame: 4 hours
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 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 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 4 hours post randomization between the 2 treatment arms, separately for Group A and B
Time frame: 4 hours
Occurrence of any 5-day bleeding event (BARC Types 1-5)
Time frame: 5 days
Occurrence of 5-day MACEs
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Alexopoulos, MD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor in people with ST-elevation Myocardial Infarction, run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.