Rationale and design of COLchicine On-admission to Reduce inflammation in Acute Coronary Syndrome (COLOR-ACS) study

Aims: The aim of the colchicine on-admission to reduce inflammation in acute coronary syndrome (COLOR-ACS) study is to evaluate the effects of the addition of short-term, low-dose colchicine to high-dose atorvastatin in limiting levels of inflammatory markers, such as high-sensitivity C-reactive protein (hs-CRP), in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). Methods: The COLOR-ACS study is a multicenter, randomized, open-label, two-arm trial. Statin-naive patients with NSTE-ACS, scheduled for an early invasive strategy, are randomized on admission to receive standard treatment of atorvastatin 80 mg or standard treatment plus colchicine (1 mg loading dose followed by 0.5 mg/day until discharge). The main exclusion criteria are prior statin and/or colchicine treatment, current treatment with potent inhibitors of CYP3A4, P-glycoprotein or immunosuppressive drugs, known active malignancy, severe kidney, cardiac, liver disease. There is clinical and biochemical follow-up at 30 days after discharge and telephone interview at 6 months. The primary end point is the change in hs-CRP from admission to discharge. Secondary end points include: incidence of acute kidney injury; MB fraction of creatine kinase peak value; glomerular filtration rate change from baseline to 30 days; persistence of hs-CRP ≥2 mg/dl at 30 days; adverse clinical events within 30 days; tolerance to colchicine. Conclusion: The COLOR-ACS study will provide evidence on the efficacy of early short-term treatment with colchicine in addition to high-dose atorvastatin compared to atorvastatin alone in ACS patients. The potential anti-inflammatory action of colchicine plus atorvastatin is expected to limit hs-CRP increase with resultant clinical benefits. Trial registration: ClinicalTrials.gov; NCT05250596

Short-term reproducibility of non-dipping pattern in type 2 diabetic hypertensive patients

Background: Little information is available on the reproducibility of nocturnal variations in blood pressure in type 2 diabetic hypertensive patients. Objective: We aimed to compare the intrasubject short-term reproducibility of a nocturnal non-dipping pattern and the prevalence of cardiac and extracardiac signs of target organ damage, in a group of type 2 diabetic hypertensive patients and in an age/gender-matched group of non-diabetic hypertensive subjects. Methods: Thirty-six treated hypertensive patients with long-lasting type 2 diabetes (&rt; 10 years duration) consecutively attending our hospital out-patient hypertension clinic (group I; mean age, 65 +- 9 years), and 61 untreated non-diabetic subjects with grade 1 and grade 2 uncomplicated essential hypertension, matched for age and gender, and chosen from patients attending an outpatient clinic (group II; mean age, 65 +- 5 years), were considered for this anal. All patients underwent blood sampling for routine blood chem., 24-h urine collection for microalbuminuria, two 24-h periods of ambulatory blood pressure monitoring (ABPM) within a 4-wk period, echocardiog., and carotid ultrasonog. A dipping pattern was defined as a greater than 10% redn. in the av. systolic and diastolic blood pressure at night compared with av. daytime values. Results: A reproducible nocturnal dipping and non-dipping profile was found in 11 (30.6%) and 21 (58.3%) diabetic patients, resp.; while only in four (11.1%) patients was a variable dipping profile obsd. Of the 23 patients with a non-dipping pattern during the first ABPM period, 21 (91.3%) also had this type of pattern during the second ABPM recording. In group II (non-diabetic hypertensive patients), 30 patients (49.2%, P < 0.05) had a dipping pattern, 13 patients (21.3%, P < 0.01) had a non-dipping profile pattern and 18 patients (29.5%, P < 0.01) had a variable dipping pattern. Of the 20 patients with a non-dipping pattern during the first ABPM period, 13 (65.0%) confirmed this type of pattern during the second ABPM recording. Finally, the prevalence of left ventricular hypertrophy (77.7 vs. 41.4%, P < 0.01), carotid plaques (80.5 vs. 38.3%, P < 0.01), carotid intima-media thickening (54.3 vs. 44.0%, P < 0.05) and microalbuminuria (11.1 vs. 2.0%, P < 0.01) was significantly higher in group I than in group II. According to a logistic regression anal., diabetes, left ventricular hypertrophy and carotid plaques were the main independent predictors of the non-dipping (pattern in the overall population. Conclusions: These findings indicate that intrasubject variability of non-dipper pattern is lower in diabetic than in non-diabetic hypertensive patients, that classification of diabetic hypertensive patients as dipper or non-dipper on the basis of a single ABP recording is more reliable than in non-diabetic patients, and that the more frequent and reproducible non-dipping (pattern in diabetic patients is assocd. with a more prominent cardiac and extracardiac target organ damage. [on SciFinder (R)