Diabetes Mellitus Clinical Trial
— AUGEASOfficial title:
30-d Rand, Eval-blind, Controlled, Multi-centre, Parallel, ph III Study to Evaluate Effect of a Low Maint Dose Ticagrelor Regimen vs Standard Dose Clopidogrel on Coronary Flow Reserve in DM Patients With Impaired Microvascular Function Without Prior MI or Stroke Undergoing ePCI.
Verified date | April 2020 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to test the hypothesis that ticagrelor is superior to clopidogrel, in improving coronary microvascular function, as measured by coronary flow reserve (CFR) in patients with T2DM at high risk of cardiovascular (CV) events undergoing elective PCI.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2022 |
Est. primary completion date | October 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Men or women =18 years of age 3. Diagnosed with T2DM defined as treatment with ongoing glucose lowering drug (oral medications and/or insulin) for at least 1 month 4. Presence of CAD undergoing elective PCI 5. Impaired coronary microvascular function post PCI as defined by a CFR =2.5 (as per local reading) 6. TIMI 3 flow post PCI Exclusion Criteria: 1. Previous MI defined as a documented hospitalization with a final diagnosis of spontaneous MI (with the exception of definite secondary MI [e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia]). 2. Previous stroke (transient ischemic attack [TIA] is not included in the stroke definition) 3. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI 4. On treatment with clopidogrel, prasugrel, or ticagrelor due to a prior acute major CV event (MI or stroke) (on treatment with clopidogrel due to prior vascular intervention not secondary to a major CV event is allowed) 5. Planned use of aspirin treatment at doses >150 mg od 6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study: 1. Strong CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir 2. CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily 7. Hypersensitivity to ticagrelor or any of its excipients 8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin 9. Patients with known bleeding diathesis or coagulation disorder 10. History of intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization 11. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third-degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker 12. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy) 13. Renal failure requiring dialysis 14. Known platelet count <145 x109 platelets/L 15. Known hemoglobin <9 g/dL 16. Women of child-bearing potential (WOCBP)*, who are not willing to use a method of contraception that is considered highly reliable** per CTFG (Clinical Trial Facilitation Group), OR who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding 17. Inability of the patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study 18. Life expectancy of less than 6 month based on investigator's judgement 19. Participation in another clinical study with an investigational (defined as non-approved) product, if taken within five half-lives or 28 days prior to the first administration of the trial medication, whichever is longer 20. Previous randomization in the present study 21. Severe asthma 22. Hypersensitivity to adenosine or mannitol 23. Long QT syndrome 24. Chronic obstructive lung disease, with evidence of bronchospasm 25. Severe low blood pressure 26. Unstable angina pectoris 27. Severe heart failure 28. Hypovolemia 29. Treatment with dipyradimol 30. Increased intracranial pressure * fertile, following menarche until becoming post-menopausal, unless permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) ** estrogen/progestogen or progestogen (oral, intravaginal or transdermal administration); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Region Skane | AstraZeneca, Hippocrates Research, IHF GmbH - Institut für Herzinfarktforschung, IRW consulting AB |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary Flow Velocity Reserve (CFR) | Difference in mean of individual absolute change from baseline to 30 days in Coronary Flow Velocity Reserve (CFR) in the mid-distal segment of the left anterior descending (LAD) coronary artery under adenosine infusion measured by Transthoracic Doppler Echocardiography (TDE) between the two arms | 30+/- 3 days after randomization | |
Secondary | Coronary flow parameter-LAD hyperemic mean diastolic flow velocity | Difference in mean of individual absolute change from baseline at 30 days in: - LAD hyperemic mean diastolic flow velocity |
30+/- 3 days after randomization | |
Secondary | Coronary flow parameter-LAD resting mean diastolic flow velocity | Difference in mean of individual absolute change from baseline at 30 days - LAD resting mean diastolic flow velocity |
30+/- 3 days after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |