Coronary Artery DiseaseTicagrelorNCT02323971
Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients
An observational study of Coronary Artery Disease, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Dec 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD and with normal renal function
Who may be able to join
- Patients presenting with moderate-high risk non-STEACS defined according the current guidelines
- Patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care
- Age between 18 and 80 years old
- BMI between 18 and 35 kg/m2
- Provide written informed consent prior to any study specific procedures
Who cannot join
- History of hemorrhagic stroke or intracranial bleeding
- Known allergies to aspirin, ticagrelor, or clopidogrel
- On treatment with oral anticoagulation (Coumarin derivate, dabigatran, rivaroxaban, apixaban)
- Hemoglobin <10 gm/dL
- Platelet count <80x106/mL
- Blood dyscrasias, active bleeding or hemodynamic instability.
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- Patients on hemodialysis or peritoneal dialysis, a change in estimated glomerular filtration rate (eGFR) greater than 15 mL/min within 90 days prior to enrollment, or estimated glomerular filtration rate (eGFR) lower than 15 mL/min/1.73m2
- Patients with known infectious diseases or neoplasia
- Baseline ALT >2.5 times the upper limit of normal
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection
- Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid). Since omeprazole is the most used proton-pump inhibitor in our clinical environment, we will keep the same prescription rate in both groups to avoid differences results from this described interaction
- Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Tello-Montoliu MD Antonio contact
Tello-Montoliu MD Antonio contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
About this study
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events.
Read the detailed description
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events . However, there is a considerable number of patients who continue to have recurrent ischemic events despite this regimen . In fact, in the last years several clinical factors have been associated with impaired clopidogrel-induced effects. Moreover, these clinical factors are strongly related with the presence of high on-treatment platelet reactivity (HPR), which is also associated with the occurrence of adverse thrombotic events, including stent thrombosis, despite correct treatment compliance. Diabetes mellitus, acute coronary syndromes, obesity or chronic kidney disease (CKD) are common examples . This observation encourages the search for new more potent antiplatelet therapies. A new P2Y12 receptor antagonist, ticagrelor, has been approved for clinical use . Ticagrelor is a new non-thienopyridine, a cyclopentyltriazolo-pyrimidine (CPTP), direct acting reversible P2Y12 antagonist. This compound has a more favorable pharmacokinetic (PK) and pharmacodynamics (PD) profile than clopidogrel , which has translated into better clinical outcomes in patients with acute coronary syndrome (ACS) in a recent large, international clinical trial . Interestingly, ticagrelor has showed an impressive clinical benefit in patients with CKD in comparison with those patients without renal impairment .
CKD is highly associated with an increased risk of atherothrombotic events, including stent thrombosis, in patients with CAD . PD studies have shown that patients with impaired renal function are characterized by reduced clopidogrel-induced antiplatelet effects and higher rates of HPR compared with patients with preserved renal function.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet reactivity units
The primary endpoint is the comparison of the platelet reactivity units (PRU) values determined by VerfifyNow-P2Y12 system between normal renal function and CKD patients after 7±2 days of concomitant treatment with ticagrelor.
Measured: 7+2 days of treatment
Secondary outcomes (3)
platelet reactivity profiles after loading dose of ticagrelor
To evaluate platelet reactivity profiles after loading dose of ticagrelor using a 180 mg loading dose at 30 min, 1, 2, 4 and 6 hours, and comparing CKD to non-CKD patients as measured with VerifyNow-P2Y12 system.
Measured: 30 min, 1, 2, 4 and 6 hours
platelet reactivity profiles after 180 mg loading dose to ticagrelor usin MEA
To analyze platelet reactivity profiles after 180 mg loading dose to ticagrelor using MEA, at 30 min, 1, 2, 4 and 6 hours and after 90 mg b.i.d maintenance dose of ticagrelor at 7±2 days.
Measured: 30 min, 1, 2, 4 and 6 hours
ticagrelor active metabolite levels
To assess ticagrelor active metabolite levels after loading dose of ticagrelor using a 180 mg loading dose at 30 min, 1, 2, 4 and 6 hours, and comparing CKD to non-CKD patients.
Measured: 30 min, 1, 2, 4 and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tello-Montoliu MD Antonio, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323971
- Sponsor's protocol ID
- FFI-TIC-2014-01
- Acronym
- Ticagrelor
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2014
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT02323971
- Acronym / sponsor ID
- Ticagrelor / FFI-TIC-2014-01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Dec 2014 (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.
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events.
Detailed description
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events . However, there is a considerable number of patients who continue to have recurrent ischemic events despite this regimen . In fact, in the last years several clinical factors have been associated with impaired clopidogrel-induced effects. Moreover, these clinical factors are strongly related with the presence of high on-treatment platelet reactivity (HPR), which is also associated with the occurrence of adverse thrombotic events, including stent thrombosis, despite correct treatment compliance. Diabetes mellitus, acute coronary syndromes, obesity or chronic kidney disease (CKD) are common examples . This observation encourages the search for new more potent antiplatelet therapies. A new P2Y12 receptor antagonist, ticagrelor, has been approved for clinical use . Ticagrelor is a new non-thienopyridine, a cyclopentyltriazolo-pyrimidine (CPTP), direct acting reversible P2Y12 antagonist. This compound has a more favorable pharmacokinetic (PK) and pharmacodynamics (PD) profile than clopidogrel , which has translated into better clinical outcomes in patients with acute coronary syndrome (ACS) in a recent large, international clinical trial . Interestingly, ticagrelor has showed an impressive clinical benefit in patients with CKD in comparison with those patients without renal impairment .
CKD is highly associated with an increased risk of atherothrombotic events, including stent thrombosis, in patients with CAD . PD studies have shown that patients with impaired renal function are characterized by reduced clopidogrel-induced antiplatelet effects and higher rates of HPR compared with patients with preserved renal function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD and with normal renal function
Key inclusion criteria (5 listed)
- Patients presenting with moderate-high risk non-STEACS defined according the current guidelines
- Patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care
- Age between 18 and 80 years old
- BMI between 18 and 35 kg/m2
- Provide written informed consent prior to any study specific procedures
Key exclusion criteria (13 listed)
- History of hemorrhagic stroke or intracranial bleeding
- Known allergies to aspirin, ticagrelor, or clopidogrel
- On treatment with oral anticoagulation (Coumarin derivate, dabigatran, rivaroxaban, apixaban)
- Hemoglobin <10 gm/dL
- Platelet count <80x106/mL
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 | – |
Primary outcome
platelet reactivity units
Time frame: 7+2 days of treatment
The primary endpoint is the comparison of the platelet reactivity units (PRU) values determined by VerfifyNow-P2Y12 system between normal renal function and CKD patients after 7±2 days of concomitant treatment with ticagrelor.
3 secondary outcomes
platelet reactivity profiles after loading dose of ticagrelor
Time frame: 30 min, 1, 2, 4 and 6 hours
platelet reactivity profiles after 180 mg loading dose to ticagrelor usin MEA
Time frame: 30 min, 1, 2, 4 and 6 hours
ticagrelor active metabolite levels
Time frame: 30 min, 1, 2, 4 and 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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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.
Tello-Montoliu MD Antonio contact
Tello-Montoliu MD Antonio contact
Tello-Montoliu MD Antonio principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 5 inclusion and 13 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 14 Dec 2017. 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 Spain. 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.
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?
Contact Tello-Montoliu MD Antonio (atellomont@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet reactivity units (time frame: 7+2 days of treatment). 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 14 Dec 2017.