Cardiovascular DiseasePhase 4NCT02012140
Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Stable Angina, NSTEMI and STEMI Undergoing PCI
A Phase 4 study testing ticagrelor in people with Cardiovascular Disease and Stable Angina, run by LifeBridge Health at 1 site in United States.
Trial summary
Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Stable Angina, Myocardial Infarction
- What is being tested?
- ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable Angina: Stable coronary artery disease patients with documented ischemia undergoing elective PCI will be enrolled.Inclusion criteria for enrollment in the ACS group with or without ST-segment elevation, requires onset of symptoms during the previous 48 hours.
- NSTEMI
- For patients who had an ACS without ST-segment elevation (NTSEMI), two of the following criteria had to be met:
- a positive test of a biomarker (troponin I) in accordance with the universal definitions indicating myocardial necrosis
- ST-segment changes on electrocardiography, indicating ischemia that do not meet criteria for STEMI.
- STEMI
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- For patients who had an ACS with ST-segment elevation, the following two inclusion criteria had to be met:
- either persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block; and
- the intention to perform primary PCI with 24 hours of symptom onset
Who cannot join
- Patients who are on P2Y12 receptor blockers, oral anticoagulants, or GPIIb/IIIa receptor blocker therapies.
- Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
- History of refractory ventricular arrhythmias or an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
- History or evidence of congestive heart failure (New York Heart Association Class III or above ≤ 6 months before screening
- Severe hepatic impairment defined as ALT> 2.5 X ULN
- Uncontrolled hypertension, or systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening
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- Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis
- Platelet count <100 X103, illicit drug or alcohol abuse, prothrombin time>1.5 times control, haematocrit <30%, and creatinine >2.0 mg/dl.
- Contraindication or other reason that ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- Fibrinolytic therapy in the 24 hours prior to PCI, or planned fibrinolytic treatment following PCI.
- Participation in another investigational drug or device study in the last 30 -Pregnancy or lactation
- Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study
- Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
- Substrates with narrow therapeutic index: cyclosporine, quinidine
- Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine
- Any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study (eg, cardiogenic shock or severe haemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215
Kevin Bliden, MBA, 410-601-4795, kbliden@lifebridgehealth.org
About this study
Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS). The benefit of this study would be to demonstrate that ticagrelor therapy is associated with equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.
- Being tested
- ticagrelor
- Medical subject headings
- Cardiovascular Diseases, Angina, Stable, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | As per ACC/AHA and ESC guidelines 180 mg is the recommended LD. The ticagrelor 90 mg BID dose, following the loading dose, has been selected for the clopidogrel naïve patients with stable angina, NSTEMI and STEMI patients undergoing PCI as the maintenance dose for this study since it is the FDA recommended dose. Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation
The primary end point is the pharmacodynamic (inhibition of platelet aggregation, IPA) effect of 180mg LD ticagrelor measured at 1hour post-dose by 20uM ADP-induced maximum platelet aggregation
Measured: Pre-LD dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study MD dose (14 +/- 3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul A. Gurbel, LifeBridge Health
- Investigators
- Paul Gurbel, MD, Principal investigator, Sinai Center for Thrombosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012140
- Sponsor's protocol ID
- AZSC01
- Status last verified
- Dec 2013
- First submitted
- 5 Nov 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Stable Angina, NSTEMI and STEMI Undergoing PCI
- ClinicalTrials.gov ID
- NCT02012140
- Acronym / sponsor ID
- AZSC01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- First posted
- 16 Dec 2013 (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.
Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS). The benefit of this study would be to demonstrate that ticagrelor therapy is associated with equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: ticagrelorAs per ACC/AHA and ESC guidelines 180 mg is the recommended LD. The ticagrelor 90 mg BID dose, following the loading dose, has been selected for the clopidogrel naïve patients with stable angina, NSTEMI and STEMI patients undergoing PCI as the maintenance dose for this study since it is the FDA recommended dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stable Angina: Stable coronary artery disease patients with documented ischemia undergoing elective PCI will be enrolled.Inclusion criteria for enrollment in the ACS group with or without ST-segment elevation, requires onset of symptoms during the previous 48 hours.
- NSTEMI
- For patients who had an ACS without ST-segment elevation (NTSEMI), two of the following criteria had to be met:
- a positive test of a biomarker (troponin I) in accordance with the universal definitions indicating myocardial necrosis
- ST-segment changes on electrocardiography, indicating ischemia that do not meet criteria for STEMI.
Key exclusion criteria (16 listed)
- Patients who are on P2Y12 receptor blockers, oral anticoagulants, or GPIIb/IIIa receptor blocker therapies.
- Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
- History of refractory ventricular arrhythmias or an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
- History or evidence of congestive heart failure (New York Heart Association Class III or above ≤ 6 months before screening
- Severe hepatic impairment defined as ALT> 2.5 X ULN
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 |
|---|---|---|
| ticagrelor | Drug | Ticagrelor |
Primary outcome
Inhibition of platelet aggregation
Time frame: Pre-LD dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study MD dose (14 +/- 3 days).
The primary end point is the pharmacodynamic (inhibition of platelet aggregation, IPA) effect of 180mg LD ticagrelor measured at 1hour post-dose by 20uM ADP-induced maximum platelet aggregation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
Sinai Center for Thrombosis Research
Baltimore, United States
Paul Gurbel, MD principal investigator
Sinai Center for Thrombosis Research
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 Cardiovascular Disease and Stable Angina, run by LifeBridge Health at 1 site in United States.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 16 Dec 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition of platelet aggregation (time frame: Pre-LD dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study MD dose (14 +/- 3 days).). 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 16 Dec 2013.