The aim of the study is to use Exenatide long-acting release (LAR) \[Bydureon\] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.
Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI. Primary objectives: To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts Secondary objectives: To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
2 mg Once Weekly
Humulin kwickpen 10U QD at bedtime
Metformin 1g BID
Dept of clinical science and education Karolinska Institutet Södersjukhuset
Stockholm, Other, Sweden
The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT).
Time frame: 12 weeks
Fractional Flow Reserve (FFR)
FFR is a unitless index calculated as the ratio between distal coronary and aortic pressure during maximum hyperemia.
Time frame: 12 weeks
Coronary Flow velocity Reserve (CRF)
CFR is a unitless index calculated as the ratio between the the mean transit time recorded at maximum hyperemia and at baseline using the thermodilution.
Time frame: 12 weeks
Index of Microcirculatory Resistance (IMR)
IMR is a unitless index calculated by dividing the mean distal coronary pressure by the inverse of the mean transit time recorded using the thermodilution technique during maximum hyperemia
Time frame: 12 weeks
Fractional flow reserve positive re-stenosis
Time frame: 12 weeks
Target lesion failure
Need of unplanned PCI in the treated stenosis or significant re-stenosis in the follow-up
Time frame: 12 weeks
Acute coronary syndrome (ACS) and/or repeat revascularization
Time frame: 12 weeks
Late lumen loss/neointima thickness measured with OCT
Time frame: 12 weeks
Change in minimal lumen area by OCT
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Time frame: 12 weeks
Left ventricular systolic and diastolic function assessed by echocardiography
Time frame: 12 weeks
Recovery from endothelial damage, measured by high resolution ultrasound, after PCI
Non-invasive ultrasound over the radialis artery after the PCI procedure using Standard 6-7F guiding catheters.
Time frame: 12 weeks
Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels
Time frame: 12 weeks
Plasma markers of inflammation i.e., CRP, IL-1β, IL-6 and IL-8.
Time frame: 12 weeks
Plasma markers of matrix remodeling enzymes i.e., MMP-2 and MMP9
Time frame: 12 weeks
Circulating endothelial progenitor cells
Time frame: 12 weeks
Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS)
Time frame: 12 weeks