Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor (HEIGHTEN)
|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.Drug: Ticagrelor
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869309
|Contact: Kevin P Bliden, BS, MBAemail@example.com|
|United States, Maryland|
|Sinai Center for Thrombosis Research||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Kevin P Bliden, B.S. MBA 410-601-4795 firstname.lastname@example.org|
|Contact: Tania B Gesheff, MSN 4106014795 email@example.com|
|Principal Investigator:||Paul A Gurbel, MD||LifeBridge Health|