NCT02370680

Brief Summary

This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

February 11, 2015

Last Update Submit

August 4, 2015

Conditions

Cardiovascular Disease

Keywords

AntiplateletAntiplatelet therapyplatelet turnoverhigh platelet turnoverplatelet aggregationcardiovascular diseasecoronary artery diseasediabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • change in platelet aggregation

    During the 26-hour hospital stays, outcomes will be measured at various timepoints

Secondary Outcomes (2)

  • Reactive Hyperemia Index

    During the 26-hour hospital stays, outcomes will be measured at various timepoints

  • Safety as measured by the number and system class of adverse events reported in each treatment arm

    participants are followed for approximately 40 to 65 days once they start study medication

Other Outcomes (2)

  • Serum Thromboxane

    During the 26-hour hospital stays, outcomes will be measured at various timepoints

  • urinary metabolites of prostacyclin and thromboxane

    During the 26-hour hospital stays, outcomes will be measured at various timepoints

Study Arms (2)

Durlaza™, 1 capsule

EXPERIMENTAL

Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit

Drug: AspirinDrug: Durlaza™

Durlaza™, 2 capsules

EXPERIMENTAL

in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit

Drug: AspirinDrug: Durlaza™

Interventions

AspirinDRUG

steady-state run-in prior to Durlaza treatment

Also known as: Bayer aspirin
Durlaza™, 1 capsuleDurlaza™, 2 capsules
Durlaza™DRUG

comparison of different numbers of capsules

Durlaza™, 1 capsuleDurlaza™, 2 capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-lactating, non-pregnant female subjects
  • A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)

You may not qualify if:

  • Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),
  • Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,
  • Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Platelet and Thrombosis Research, LLC

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseDiabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Paul Gurbel, MD

    Platelet Thrombosis Research, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 25, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

US(1)