Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor (HEIGHTEN)
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|ClinicalTrials.gov Identifier: NCT01869309|
Recruitment Status : Unknown
Verified December 2013 by LifeBridge Health.
Recruitment status was: Recruiting
First Posted : June 5, 2013
Last Update Posted : November 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Prasugrel Drug: Ticagrelor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
No Intervention: Non-HPR group
The non-HPR group will have PD and genetic testing, with no change in medication.
Active Comparator: HPR Group
This arm will be split into Group A and Group B which will receive Ticagrelor/Prasugrel in a crossover manner.
Patients will discontinue ticagrelor treatment and start 10 mg prasugrel daily while continuing 81 mg of aspirin daily.
Patients will be given 180 mg of Ticagrelor followed by 90 mg twice a day while continuing 81 mg of aspirin daily).
- 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%.
- Prevalence of HPPR [ Time Frame: 2 hours, 4 hours, and 14 days ]Determine the prevalence of HPPR in a stable PCI population.
- CYP2C19 relation to occurence of HPPR [ Time Frame: 2 hours, 4 hours, and 14 days ]Determine the relation of CYP2C19 activity to the occurrence of HPPR.
- PD VerifyNow in HPPR stable CAD patients [ Time Frame: 2 hour, 4 hour, 14 days ]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
- PD LTA in HPPR stable CAD patients [ Time Frame: 2 hours, 4 hours, 14 days ]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)
- Frequency of HPR [ Time Frame: 2 hours, 4 hours, and 14 days ]To determine the frequency of HPR after switching from ticagrelor to prasugrel after 14 days of treatment.
- PD effect(Prasugrel) relation to CYP2C19 [ Time Frame: 2 hours, 4 hours, and 14 days ]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.
- Number of Participants with Adverse Events [ Time Frame: 14 days, 28 days ]To evaluate the safety and tolerability of switching subjects from Prasugrel to Ticagrelor and vice versa.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869309
|Contact: Kevin P Bliden, BS, MBAfirstname.lastname@example.org|
|United States, Maryland|
|Sinai Center for Thrombosis Research||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Kevin P Bliden, B.S. MBA 410-601-4795 email@example.com|
|Contact: Tania B Gesheff, MSN 4106014795 firstname.lastname@example.org|
|Principal Investigator:||Paul A Gurbel, MD||LifeBridge Health|