Coronary Artery DiseasePhase 4HEIGHTENNCT01869309
Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor
A Phase 4 study testing Prasugrel and Ticagrelor in people with Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
Trial summary
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) >50%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prasugrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- 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
- Male or female; age ≥ 18 and < 75 years
- Weight ≥ 60 kg
- Currently on ASA therapy and eligible to reduce ASA dose to 81 mg daily if on higher dosing
- On stable prasugrel maintenance dose for ≥1 month
- Stable CAD patients defined as: subjects with documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization (defined as either a prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery). A minimum of 1 month must have elapsed between a subject's enrolment and any acute event, revascularization procedure or hospitalization for chest pain for that subject.
- If female, may be enrolled if one of the following 3 criteria are met: 1)Had a hysterectomy or tubal ligation at least 6 months prior to signing ICF, 2)Post-menopausal for at least 1 year, 3)If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.
- Able and willing to provide written informed consent before entering the study
Who cannot join
- Subject plans to undergo coronary revascularization at any time during the trial
- 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 with 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
- Concomitant use with parenteral or oral anticoagulants
- Platelet count <100 X103
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215
Kevin P Bliden, B.S. MBA, 410-601-4795, kbliden@lifebridgehealth.org
Tania B Gesheff, MSN, 4106014795, tgesheff@lifebridgehealth.org
About this study
Official title: Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) >50%.
- Conditions
- Coronary Artery Disease
- Being tested
- Prasugrel, Ticagrelor
- Keywords
- Coronary artery disease, anti-platelet medications, Platelet-aggregation Inhibitors
- 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.
PrasugrelDrug
Patients will discontinue ticagrelor treatment and start 10 mg prasugrel daily while continuing 81 mg of aspirin daily.
TicagrelorDrug
Patients will be given 180 mg of Ticagrelor followed by 90 mg twice a day while continuing 81 mg of aspirin daily).
| Study group | Role | What they receive |
|---|---|---|
| Non-HPR group | No intervention | The non-HPR group will have PD and genetic testing, with no change in medication. |
| HPR Group | Active comparator | This arm will be split into Group A and Group B which will receive Ticagrelor/Prasugrel in a crossover manner. Receives: Drug: Prasugrel; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic (PD) Vasodilator Stimulated Phosphoprotein-Phosphorylation(VASP-P) in High On Prasugrel Platelet Reactivity(HPPR) stable CAD patients
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit high-on prasugrel platelet reactivity defined as VASP-P>50%.
Measured: 2 hours, 4 hours, and 14 days
Secondary outcomes (6)
Prevalence of HPPR
Determine the prevalence of HPPR in a stable PCI population.
Measured: 2 hours, 4 hours, and 14 days
CYP2C19 relation to occurence of HPPR
Determine the relation of CYP2C19 activity to the occurrence of HPPR.
Measured: 2 hours, 4 hours, and 14 days
PD VerifyNow in HPPR stable CAD patients
Evaluate the PD effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit HPPR defined as PRU >208 by VerifyNow P2Y12
Measured: 2 hour, 4 hour, 14 days
PD LTA in HPPR stable CAD patients
Evaluate the PD effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit HPPR based on light transmittance aggregometry (5 and 20 uM ADP, 4ug/mL Collagen)
Measured: 2 hours, 4 hours, 14 days
Frequency of HPR
To determine the frequency of HPR after switching from ticagrelor to prasugrel after 14 days of treatment.
Measured: 2 hours, 4 hours, and 14 days
PD effect(Prasugrel) relation to CYP2C19
To determine if the PD effect of prasugrel is related to the activity of CYP2C19 (phenotyping and genotyping) by measuring patients with and without HPPR.
Measured: 2 hours, 4 hours, and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Paul A Gurbel, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869309
- Sponsor's protocol ID
- 2015
- Other IDs
- ISSBRIL0149
- Acronym
- HEIGHTEN
- Status last verified
- Dec 2013
- First submitted
- 28 May 2013
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy
- ClinicalTrials.gov ID
- NCT01869309
- Acronym / sponsor ID
- HEIGHTEN / 2015
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, anti-platelet medications, Platelet-aggregation Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Jun 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.
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) >50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-HPR group | No intervention | –The non-HPR group will have PD and genetic testing, with no change in medication. |
| HPR Group | Active comparator | Drug: Prasugrel, Drug: TicagrelorThis arm will be split into Group A and Group B which will receive Ticagrelor/Prasugrel in a crossover manner. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female; age ≥ 18 and < 75 years
- Weight ≥ 60 kg
- Currently on ASA therapy and eligible to reduce ASA dose to 81 mg daily if on higher dosing
- On stable prasugrel maintenance dose for ≥1 month
- Stable CAD patients defined as: subjects with documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization (defined as either a prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery). A minimum of 1 month must have elapsed between a subject's enrolment and any acute event, revascularization procedure or hospitalization for chest pain for that subject.
Key exclusion criteria (9 listed)
- Subject plans to undergo coronary revascularization at any time during the trial
- 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 with 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 |
|---|---|---|
| PrasugrelPatients will discontinue ticagrelor treatment and start 10 mg prasugrel daily while continuing 81 mg of aspirin daily. | Drug | HPR Group |
| TicagrelorPatients will be given 180 mg of Ticagrelor followed by 90 mg twice a day while continuing 81 mg of aspirin daily). | Drug | HPR Group |
Primary outcome
Pharmacodynamic (PD) Vasodilator Stimulated Phosphoprotein-Phosphorylation(VASP-P) in High On Prasugrel Platelet Reactivity(HPPR) stable CAD patients
Time frame: 2 hours, 4 hours, and 14 days
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit high-on prasugrel platelet reactivity defined as VASP-P>50%.
6 secondary outcomes
Prevalence of HPPR
Time frame: 2 hours, 4 hours, and 14 days
CYP2C19 relation to occurence of HPPR
Time frame: 2 hours, 4 hours, and 14 days
PD VerifyNow in HPPR stable CAD patients
Time frame: 2 hour, 4 hour, 14 days
PD LTA in HPPR stable CAD patients
Time frame: 2 hours, 4 hours, 14 days
Frequency of HPR
Time frame: 2 hours, 4 hours, and 14 days
PD effect(Prasugrel) relation to CYP2C19
Time frame: 2 hours, 4 hours, and 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Paul A Gurbel, MD principal investigator
LifeBridge Health
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 Prasugrel and Ticagrelor in people with Coronary Artery Disease, 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 7 inclusion and 9 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 21 Nov 2014. 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?
Contact Kevin P Bliden, BS, MBA (4106014795, kbliden@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic (PD) Vasodilator Stimulated Phosphoprotein-Phosphorylation(VASP-P) in High On Prasugrel Platelet Reactivity(HPPR) stable CAD patients (time frame: 2 hours, 4 hours, and 14 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 21 Nov 2014.