Comparison · NCT00535925-33953a86
Conventional Therapy vs Intensified Therapy: Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Conventional Therapy vs Intensified Therapy: Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs). Trial comparisons, record NCT00535925-33953a86. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00535925-33953a86
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.777 | 0.712 | 0.83 | wilson | |
| Risk in group 2 | 0.56 | 0.492 | 0.626 | wilson | |
| Risk difference, group 1 minus group 2 | 0.216 | 0.124 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 1.2 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 2.73 | 1.76 | 4.23 | log | |
| Number needed to treat, for one more participant with the outcome on Conventional Therapy than on Intensified Therapy | 4.63 | 3.3 | 8.08 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Conventional Therapy | Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~current therapy: the patients have to be treated according the standard good medical practice by any center | 146 | 188 | OG000 |
| Group 2 | Intensified Therapy | Intensive multifactorial intervention is performed to achieve goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. New antihypertensive drugs will be added one by one until achievement of BP target (\<130/80 mmHg).~Therapy for Hypertension~1. Step1 - irbesartan 300 mg/die and ramipril 10 mg/die~2. Step 2 (Diuretic) - hydrochlorothiazide 12.5-25 mg/die, if creatinine \<2 mg/dL / furosemide 25-75 mg/die, if creatinine ≥2 mg/dL~3. Step 3 - amlodipine up to 10 mg/die~4. Step 4 - atenolol up to 100 mg/die~5. Step 5 - doxazosin up to 4 mg/die~6. Step 6 - Clonidine~Therapy for Hyperglycaemia (to achieve HbA1c \<7): insulin~Therapy for hypercholesterolemia (to reduce LDL \<100 mg/dl) --\> simvastatin till 80 mg/die~Therapy for hypertriglyceridemia (to reduce triglycerides \<150 mg/dl and/or increase HDL \>40-50 mg/dl) --\> fibrate~Treatment of anaemia: erythropoietin~Antiplatelets (all patients without contraindications): aspirin till 160 mg/die | 116 | 207 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)
- Description
number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias.
- Time frame
- 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)
- Population
- number of MACEs reported will be at the end of the whole study period (follow-up) due to the fact that number needed to treat (NNT) at end of intervention was not reached)
Source ClinicalTrials.gov
Trial
- Title
- Nephropathy In Type 2 Diabetes and Cardio-renal Events
- NCT number
- NCT00535925
- Phases
- PHASE4
- Conditions
- Diabetic Nephropathy
- Interventions
- SoC therapy, irbesartan, ramipril, hydrochlorothiazide, furosemide, amlodipine, atenolol, doxazosin, clonidine, insulin, simvastatin, fibrate, erythropoietin, aspirin
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Results first posted
- 2020-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00535925?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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