Stable Angina Pectoris Clinical Trial
Official title:
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.
The study objective is to test whether 2-day high dose atorvastatin administration before
PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in
terms of peri-PCI cardiovascular events, as well as 6-month prognosis.
2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina
pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group
is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care.
After angiography, patients who are not undergoing PCI procedure will be excluded from the
study as selection failure. After PCI procedure, the study group is given atorvastatin
40mg/d until 30 days after PCI while the control group receive usual care. The last visit
will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST
before and after procedure will be recorded. 1100 effective patients will be finally
enrolled.
The study will be conducted at about 54 centers in China. Data will be collected on 2,100
NSTE or SAP patients undergoing PCI.
Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of
inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at
least once AST > 3ULN,ALT > 3ULN or CK > 5ULN after initiation of study treatment.
Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of
study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw
study treatment, or withdraw study due to adverse events; Combined endpoint of death,
cardiac death, myocardial infarction, heart failure, cardiac hospitalization,
revascularization, and cerebrovascular events within 6 months after PCI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01257282 -
Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)
|
N/A | |
Completed |
NCT02294942 -
Extended-Release RANCAD in the Patients With Stable Angina Pectoris
|
Phase 3 | |
Completed |
NCT02029118 -
Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
|
Early Phase 1 | |
Completed |
NCT00763464 -
Coronary Artery Disease (CAD) in Postmenopausal Women
|
N/A | |
Recruiting |
NCT02328898 -
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
|
Phase 4 | |
Completed |
NCT02339454 -
Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris
|
Phase 3 | |
Completed |
NCT01502943 -
Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index
|
Phase 4 | |
Terminated |
NCT00638326 -
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
|
Phase 3 | |
Withdrawn |
NCT02165670 -
BASIC VALIDATE Coronary Stent Registry
|
||
Completed |
NCT01632371 -
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
|
Phase 4 | |
Completed |
NCT01363661 -
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
|
Phase 4 | |
Completed |
NCT02747329 -
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
|
N/A | |
Recruiting |
NCT05347069 -
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
|
Phase 4 | |
Recruiting |
NCT04938661 -
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
|
N/A | |
Not yet recruiting |
NCT03155971 -
PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
|
N/A | |
Active, not recruiting |
NCT02285322 -
Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
|
N/A | |
Active, not recruiting |
NCT02062021 -
Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease
|
N/A | |
Active, not recruiting |
NCT01947361 -
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
|
N/A | |
Active, not recruiting |
NCT01937065 -
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study
|
N/A | |
Completed |
NCT01669382 -
Angio-Seal® vs. Exo-Seal® for Closure of Arterial Puncture Sites
|
Phase 3 |