Coronary Artery Disease Clinical Trial
Official title:
In Patients Taking Protease Inhibitors Does Switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine Combination, Reduce Cardiovascular Risk: An Open-label, Randomised, Serial CT Pilot Study
Combined antiretroviral therapy (cART) is thought to promote coronary artery disease via a
number of mechanisms: abnormal lipid profiles, endothelial dysfunction, hypertension, insulin
resistance and renal impairment are the main pathological mechanisms driving atherosclerosis
as a consequence of cART. An association between protease inhibitors and increased
cardiovascular disease risk has been shown in many large cohort trials.
CT Coronary Angiography (CTCA) is now widely used to assess for the presence of
atherosclerosis, typically in patients presenting with chest pain. This imaging technique
allows visualisation of the coronary arteries and quantification of any atherosclerotic
disease that may be present. This technique is being increasingly used as a surrogate for
cardiovascular disease risk.
HART CT is an open label, prospective, randomised-control pilot study to investigate the
feasibility of performing a future appropriately powered multi-centred randomised control
trial using CT based outcome data as a surrogate for cardiovascular disease risk.
Participants will be randomised to either continue their usual cART or switch to Biktarvy (a
fixed dose combination of bictegravir, emtricitabine and tenofovir alafenamide). A baseline
CT scan will be performed. If there is any evidence of atherosclerosis a further CT scan will
be performed at the end of the study (approximately 48 weeks). This will allow quantification
of any change in coronary artery plaque burden or characteristic. Participants will be also
followed up for any changes in metabolic health.
n/a
| 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 | |
| Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| 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 | |
| Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
| Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |