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Completed

NCT Number: NCT02313038

Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life DES use and the efficacy and safety in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically representative highest-rank hospitals, this study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

About this study

In this study, 6000 patients who underwent the first-ever drug eluting stents (DES) deployment during the index hospitalization will be consecutively recruited in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one DES is implanted successfully in the procedure
  • Only one of the five major brands of DES is used in the procedure

Exclusion criteria

  • Prior stent implantation history

Treatment and study plan

Primary outcomes

  1. Composite of major adverse cardiac events (MACE)

    Time frame: 1 year

    Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.

Secondary outcomes

  1. Safety endpoint

    Time frame: 1 year

    Safety endpoint: stent thrombosis

  2. Efficacy composite endpoints

    Time frame: 1 year

    Efficacy composite endpoints, including cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel), and/or target lesion revascularization

  3. Status of general health

    Time frame: 1 year

    Status of general health (SF-12)

  4. Quality of life

    Time frame: 1 year

    Quality of life (EQ-5D)

  5. Symptoms status

    Time frame: 1 year

    Symptoms status (SAQ)

  6. Cost-effectiveness

    Time frame: 1 year

    Cost-effectiveness ratio: marginal cost (direct and indirect) per QALY increase, with homebred DES as the reference group

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: PEACE-DES

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Aug 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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