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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03046576
Other study ID # DPP4a-MACCE
Secondary ID
Status Completed
Phase N/A
First received February 5, 2017
Last updated July 18, 2017
Start date January 1, 2013
Est. completion date September 30, 2015

Study information

Verified date July 2017
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset atherosclerosis, and our previous study has found that the DPP4a was significantly lower in MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is associated with no-reflow and major bleeding events in STEMI patients during hospital stay. As no-reflow phenomenon and major bleeding events independently associates with a worse in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested in this study.


Recruitment information / eligibility

Status Completed
Enrollment 625
Est. completion date September 30, 2015
Est. primary completion date September 30, 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.

Exclusion Criteria:

- patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue

Study Design


Intervention

Diagnostic Test:
plasma DPP4 activity
DPP4a was determined by enzymatic assays.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

References & Publications (5)

Li JW, Chen YD, Chen WR, Jing J, Liu J, Yang YQ. Plasma DPP4 activity is associated with no-reflow and major bleeding events in Chinese PCI-treated STEMI patients. Sci Rep. 2016 Dec 21;6:39412. doi: 10.1038/srep39412. — View Citation

Niccoli G, Kharbanda RK, Crea F, Banning AP. No-reflow: again prevention is better than treatment. Eur Heart J. 2010 Oct;31(20):2449-55. doi: 10.1093/eurheartj/ehq299. Epub 2010 Sep 13. Review. — View Citation

Pellaton C, Cayla G, Silvain J, Zeymer U, Cohen M, Goldstein P, Huber K, Pollack C Jr, Kerneis M, Collet JP, Vicaut E, Montalescot G; ATOLL Investigators. Incidence and consequence of major bleeding in primary percutaneous intervention for ST-elevation myocardial infarction in the era of radial access: an analysis of the international randomized Acute myocardial infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up trial. Am Heart J. 2015 Oct;170(4):778-86. doi: 10.1016/j.ahj.2015.05.021. Epub 2015 Jul 3. — View Citation

Zheng TP, Liu YH, Yang LX, Qin SH, Liu HB. Increased plasma dipeptidyl peptidase-4 activities are associated with high prevalence of subclinical atherosclerosis in Chinese patients with newly diagnosed type 2 diabetes: a cross-sectional study. Atherosclerosis. 2015 Oct;242(2):580-8. doi: 10.1016/j.atherosclerosis.2015.07.042. Epub 2015 Jul 26. — View Citation

Zheng TP, Yang F, Gao Y, Baskota A, Chen T, Tian HM, Ran XW. Increased plasma DPP4 activities predict new-onset atherosclerosis in association with its proinflammatory effects in Chinese over a four year period: A prospective study. Atherosclerosis. 2014 Aug;235(2):619-24. doi: 10.1016/j.atherosclerosis.2014.05.956. Epub 2014 Jun 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary major adverse cardiac or cerebrovascular events including cardiovascular death, non-fatal myocardial infarction, heart failure and stroke The median follow-up was 30 months
Secondary non-cardiovascular death The median follow-up was 30 months
Secondary repeated revascularization defined as repeated PCI or bypass grafting of not only infarct related artery but also non-infarct related artery, driven by ischemic symptoms (stable/unstable angina or re-infarction) or detection of ischemia by non-invasive tests The median follow-up was 30 months
Secondary stroke defined using the World Health Organization criteria The median follow-up was 30 months
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