Coronary Artery Disease Clinical Trial
Official title:
A Single Center Phase II Assessor-Blinded RaNdomised Active Controlled Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients With CoronarY Artery Disease.
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.
This is singe-center, randomized, assessor-blinded, active controlled, parallel-group trial
consisting of an 'acute' and a 'chronic' period, aiming at comparing ticagrelor versus
clopidogrel on the reduction of arterial stiffness and wave reflections in patients with CAD.
This Investigator-Sponsored Study (ISS) will be supported by AstraZeneca.
60 subjects fulfilling all study-specific eligibility criteria will be initially recruited
for the 'acute' study period of 24-hour duration. Subjects that will undergo ad hoc PCI will
continue in the subsequent 'chronic' study period of 30-day duration.
In order to have 60 subjects in the 'chronic' study period (since some of the 'acute' period
will not undergo PCI), additional subjects that are scheduled for elective PCI will be
recruited until the sample size of 'chronic' study period reaches 60 subjects.
The study periods [Figure 1, Flow Chart] have as follows:
For the 24-hour ACUTE period, 60 subjects with an indication for elective CA with or without
PCI will be included in the study.
Three (3) hours before the CA the subjects will be randomized in the two study treatment
arms:
Ticagrelor arm: 30 subjects will receive
- 180 mg loading dose of ticagrelor,
- 1st maintenance ticagrelor dose of 90 mg at 12 hours. Clopidogrel arm: 30 subjects will
receive
- 600 mg loading dose of clopidogrel.
Study measurements (arterial stiffness, central blood pressure and endothelial function) for
both study treatment arms will be performed at:
- baseline (0 hours - prior to the loading dose administration)
- 3 hours (after the loading dose of each regimen and before CA), and at
- 24 hours (before the administration of the 2nd maintenance dose of ticagrelor and the
1st maintenance dose of clopidogrel).
For the 30-day CHRONIC period, 60 subjects that will undergo PCI (stent implantation) will be
studied. Part of this 'chronic' period population will consist of the subjects that were
included in the 'acute' period and proceeded ad hoc to PCI. The remainder will be subjects
being scheduled for elective PCI, who will be enrolled after the completion of the
recruitment in the 'acute' study period.
Approximately 30 subjects will be allocated to ticagrelor loading dose and maintenance dose
(90 mg BID) thereafter and approximately 30 subjects will be allocated to 600 mg of
clopidogrel and maintenance dose (75 mg QD) thereafter.
Study measurements for the subjects of the 'acute' period that will enter the 'chronic'
period will be performed at:
- 30 days post-PCI (prior to the administration of the morning maintenance dose of the
assigned treatment regimen at the day of study visit).
Study measurements for the additional subjects with indication of elective PCI that will be
enrolled directly into the chronic study period will be performed at:
- baseline (0 hours - prior to the administration of the loading dose of each treatment
regimen and 3 hours before the PCI)
- 30 days post PCI (prior to the administration of the morning maintenance dose of the
assigned treatment regimen at the day of study visit).
All study-related procedures will be carried out in accordance with the institutional
guidelines and common practice.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |