Compare Ticagrelor vs Clopidogrel on the Reduction of Arterial Stiffness and Wave Reflectionsin Patients With CAD.

NCT02071212 | Completed Phase 2

• 1 other identifier: D5130L00063
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential acute and chronic effect of ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects with an indication for coronary angiography (CA) with or without percutaneous coronary intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60 subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan and Procedures'). The primary objective of this study is to compare ticagrelor versus clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after the loading dose of each regimen, in eligible subjects with CAD.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change in the cfPWV

  The primary outcome is the treatment difference in the mean change in cfPWV from baseline (0 hours) at 3 hours after the loading dose of each regimen, in ticagrelor and clopidogrel acute period populations.

  at 3 hours after the loading dose

Secondary Outcomes (1)

• mean change in the cfPWV

  from baseline at 24 hours after the loading dose

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Loading dose 600 mg .Mainatinance dose 75 mg QD

Drug: Ticagrelor

Ticagrelor

EXPERIMENTAL

Loading dose 180 mg . Maintenance 90 mg BID

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Loading dose 180 mg . Maintainance dose 90 mg BID

Also known as: BRILIQUE

Clopidogrel; Ticagrelor

Eligibility Criteria

• Age: 18 Years - 79 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 and female subjects \> 18 and \< 79 years of age.

You may not qualify if:

• Who had ACS within 12 months of screening.
• Previous stent implantation with dual antiplatelet therapy within 12 months of screening.
• Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
• Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction \< 30%.
• Subjects with hemodynamic or electrical instability (including shock).
• History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
• Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
• Any previous history of ischemic or hemorrhagic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
• International Normalized Ratio (INR) known to be \>1.5 within 1 week of study entry.
• Poorly controlled blood pressure (\>160/100 mmHg).
• Known platelet count of \<100,000/mm3 within 1 week of study entry.
• Known anemia (hemoglobin \[Hb\] \<10 gr/dL) within 1 week of study entry.
• Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
• Severe kidney disease (GFR\<30 ml/min/1.73m2).
• Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia defined as peak total serum bilirubin greater than 2 times the upper limit of normal (ULN).

Sponsors & Collaborators

• Hellenic Cardiovascular Research Society: lead
• AstraZeneca: collaborator

Study Sites (1)

Ippokratio Hospital

Athens, Greece

Location

Related Publications (1)

• Vlachopoulos C, Georgakopoulos C, Pietri P, Ioakeimidis N, Koutouzis M, Vaina S, Aznaouridis K, Toutouzas K, Latsios G, Terentes-Printzios D, Rigatou A, Tousoulis D. Effect of Ticagrelor Versus Clopidogrel on Aortic Stiffness in Patients With Coronary Artery Disease. J Am Heart Assoc. 2019 Jun 18;8(12):e012521. doi: 10.1161/JAHA.119.012521. Epub 2019 Jun 5.

  PMID: 31165663 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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

Study Officials

• Charalambos Vlachopoulos

  Ippokratio Hospital Athens , Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

GR (1)