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Risk Factors Promoting Coronary Plaque Progression In China

NCT02692014 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2016-02-25

No results posted yet for this study

Summary

Coronary drug-eluting stent (DES) has been launched in China for more than ten years. Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit the progression of atherosclerosis plaque outside segments. It was shown that the progression rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which indicated that current secondary prevention for coronary heart disease (CHD) is far from the achievement of ideal conditions.

Atherosclerosis has many risk factors based on current CHD guidelines, among which the level of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins were performed in the world during the past 20 years. It was demonstrated in these studies that statins were significant to both primary and secondary preventions of CHD. What's more, the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is achieved. However, cardiovascular events were still not avoidable especially for the secondary prevention of CHD even if the level of LDL was significantly controlled under the recommended range of guidelines by high dosage of statins.

It was shown in some recent studies that high loading dosage of statins may effectively control the progression of coronary plaque. However, multiple studies found it was hard to control the progression of all patients of coronary plaque due to individual difference.

Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of all statins because of possible high safety issues and confusions about the appropriate application in Chinese patients, as well as economy burden to Chinese patients with high treatment cost. How to evaluate individual progression risk of coronary plaque and enhance risk factors control and the treatment of statins for necessary population, is currently an issue, which should be solved in the diagnosis and treatment of CHD.

The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes and chronic kidney diseases may also be associated with the progression of plaque. However, the potential impact and control are still uncertain up to date.

Based on these background, we design a retrospective study, Risk Factors Promoting Coronary Plaque Progression In China (The RIPPER Study), to solve these issues.

Conditions

Sponsors & Collaborators

  • Zhang Qi, MD

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-01-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692014 on ClinicalTrials.gov