Trial · NCT04777045
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients having a successful treatment with diltiazem, defined as normalization of at least one abnormal parameter and none of the normal parameters becoming abnormal. | 6 weeks | A normal IMR is specified as IMR \< 25, a normal CFR being a CFR \> 2 and a normal acetylcholine test is specified as one without spasm, without ischemic ECG abnormalities and without (recognizable) angina at the same acetylcholine dose used at baseline. |
| Secondary | Change in index of microvascular resistance (IMR) | 6 weeks | the delta between 1st and 2nd coronary function test |
| Secondary | Change in Coronary Flow Reserve (CFR) | 6 weeks | the delta between 1st and 2nd coronary function test |
| Secondary | Change in Acetylcholine test parameters | 6 weeks | his is defined as the difference between the dose of acetylcholine at which the baseline CFT showed signs of spasm, compared to the dose at the second CFT. This will be compared between treatment and placebo group using a multinominal logistic regression. The efficacy population will be used for this analysis. |
| Secondary | Change in Absolute flow parameters - flow (Q) (ml/min) | 6 weeks | These are derived by subtracting the outcome from the second CFT from the outcome of the first CFT. To compare change in CFT parameters between treatment and placebo group, we will use independent sample t-test. Bonferroni correction will be applied to account for multiple testing. The efficacy population will be used for this analysis. |
| Secondary | Change in Absolute flow parameters - Resistance (R) | 6 weeks | These are derived by subtracting the outcome from the second CFT from the outcome of the first CFT. To compare change in CFT parameters between treatment and placebo group, we will use independent sample t-test. Bonferroni correction will be applied to account for multiple testing. The efficacy population will be used for this analysis. |
| Other | Safety endpoints | 6 weeks | The occurrence of complications related to the coronary angiography and/or CFT will be collected, as well as adverse events related to the IMP. |
| Other | Follow-up (MACE) | 5 years | Number of major adverse cardiovascular events (MACE) at 1 and 5 year follow-up. MACE is defined as nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, all-cause death, hospitalization for heart failure. |
| Other | Change in angina frequency reporting in the patient diary | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
| Other | Change in the Seattle Angina Questionnaire (SAQ) | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
| Other | Change in RAND-36 scores | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
| Other | Change in angina CCS classification | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04777045/registered