Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.

NCT04069234 | Withdrawn Phase 3 DMC

• 1 other identifier: 2019-04160
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus; Microvascular Coronary Artery Disease

Keywords

myocardial infarction; percutaneous coronary invervention; coronary flow velocity reserve (CFR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Coronary flow parameter-LAD hyperemic mean diastolic flow velocity

  30+/- 3 days after randomization

• Coronary flow parameter-LAD resting mean diastolic flow velocity

  30+/- 3 days after randomization

Study Arms (2)

Ticagrelor

EXPERIMENTAL

ticagrelor 60mg BID for 30 Days and ASA 75 - 150 mg once daily

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

clopidogrel 75mg OD for 30 Days and ASA 75 - 150 mg once daily

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

ticagrelor 60 mg BID for 30 days

Ticagrelor

Clopidogrel DRUG

clopidogrel 75mg OD for 30 Days

Clopidogrel

Eligibility Criteria

• Age: 18 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
• Men or women ≥18 years of age
• Diagnosed with T2DM defined as treatment with ongoing glucose lowering drug (oral medications and/or insulin) for at least 1 month
• Presence of CAD undergoing elective PCI
• Impaired coronary microvascular function post PCI as defined by a CFR ≤2.5 (as per local reading)
• TIMI 3 flow post PCI

You may not qualify if:

• Previous MI defined as a documented hospitalization with a final diagnosis of spontaneous MI (with the exception of definite secondary MI \[e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia\]).
• Previous stroke (transient ischemic attack \[TIA\] is not included in the stroke definition)
• Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI
• 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)
• Planned use of aspirin treatment at doses \>150 mg od
• 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:
• Strong CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
• CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily
• Hypersensitivity to ticagrelor or any of its excipients
• Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
• Patients with known bleeding diathesis or coagulation disorder
• 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
• 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
• Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy)
• Renal failure requiring dialysis

Sponsors & Collaborators

• Region Skane: lead
• IHF GmbH - Institut für Herzinfarktforschung: collaborator
• Hippocrates Research: collaborator
• IRW consulting AB: collaborator
• AstraZeneca: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Myocardial Infarction

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: September 15, 2019
• Primary Completion: October 15, 2021
• Study Completion: March 31, 2022
• Last Updated: April 8, 2020

Record last verified: 2020-04