A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response

NCT03027934 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: ESR-14-10619
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in a cross-over design.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Aggregation Response

  Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor

  23 hr Day 5

Secondary Outcomes (1)

• Reticulated Platelet Reactivity Index (PRI)

  23 hr Day 5

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Drug: Ticagrelor; Drug: Prasugrel

Group 2

ACTIVE COMPARATOR

Drug: Ticagrelor; Drug: Prasugrel

Interventions

Ticagrelor DRUG

Ticagrelor, 90mg twice daily

Also known as: Brilinta

Group 1; Group 2

Prasugrel DRUG

Prasurgrel, 10mg once daily

Also known as: Effient

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Male or female aged 18 to 70 years, inclusive.
• Documented current medical history of diabetes controlled by either medication or diet and/or exercise.
• Women must have a negative urine pregnancy test.

You may not qualify if:

• Pregnant or lactating females, or females of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) or those who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator throughout the duration of the study or females who have a positive pregnancy test at screening.
• Weight of less than 135 lbs.
• Currently prescribed and taking clopidogrel (generic or Plavix), ticagrelor (Brilinta) or prasugrel (Effient) or have taken within the past 10 days.
• Current medications:
• PAR-1 antagonist (vorapaxar/Zontivity) or within the last month.
• Phosphodiesterase inhibitors such as cilostazol (Pletal).
• Glycoprotein IIb/IIIa inhibitors or within the last ten days (Integrilin, Aggrastat, ReoPro).
• Adenosine reuptake inhibitors such as dipyridamole (Aggrenox, Persantine)
• Coumadin.
• Heparin including low molecular weight heparin.
• Factor Xa inhibitors (e.g., enoxaparin, rivaroxaban, apixaban, and edoxaban).
• Direct thrombin inhibitors (e.g., hirudin, bivalirudin, dabigatran.
• Concomitant therapy with strong CYP3A inhibitors, such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconizole,
• Concomitant therapy with potent CYP3A inducers, such as rifampin, phenytoin, carbamazepine, and phenobarbital.
• Increased bleeding risk including:

Sponsors & Collaborators

• CirQuest Labs, LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jayaprakash Kotha

  CirQuest Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: August 28, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share