Comparison between Dipyridamole and Adenosine infusion in the evaluation of intermediate coronary restrictions (stenoses) in the cardiac catheterization laboratorY.

Dipyridamole versus Adenosine infusion in the physiologic assessment of Intermediate coronary Stenoses in the cardiac catheterization laboratorY - DAISY

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024485-21-IT

Enrollment

Registered

2013-01-15

Start date

2013-04-15

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a single = 50% e <75% coronary stenosis (visually extimated) at angiography, in one ore more coronary vessels).

Interventions

Trade Name: PERSANTIN*IV 10F 10MG/2ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: DIPYRIDAMOLE CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of any race, male or female gender, with a single = 50% e =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Known intolerance of adenosine and/or dypiridamol and/or teophylline or of the eccipients. Patients who have taken caffein or food or beverages containig caffein and/or similar substances 24 hours before the procedure. Left main or aorto-ostial lesions. Lesions in severely tortuous or calcific vessels. Severely impaired left ventricular function (EFI°. Stenosis >70% of supra-aortic vessels. Concomitant treatment with teophylline-derivatives. Concomitant therapy with phosphodiesterase inhibitors derivatives. Hypotension (PASys <100 mmHg). Atrial fibrillation. Pregnant or lactating women. Pazients with a lesion in a culprit coronary vessel in patients with prior or recent myocardial infarction. Pazients with ST-elevation myocardial infarction =5 days (lesion in non-culprit vessel).

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to assess the feasibility of dipyridamole as hyperaemia inducing agent in the Fractional Flow Reserve (FFR) assessment.;Secondary Objective: To evaluate the tolerability of dypiridamole as hyperaemia inducing agent in the measurement of FFR.;Primary end point(s): To show non inferior diagnostic accuracy of a FFR assessment with dipyridamole, infused in a peripheral vein, as pharmacological agent inducing maximal hyperaemia , compared to a continuous adenosine infusion in a central vein, considered as the “gold standard”. The diagnostic accuracy will be measured with ROC curves analysis.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The main objective of the study is to assess the feasibility of dipyridamole as hyperaemia inducing agent in the Fractional Flow Reserve (FFR) assessment.;Secondary Objective: To evaluate the tolerability of dypiridamole as hyperaemia inducing agent in the measurement of FFR.;Primary end point(s): To show non inferior diagnostic accuracy of a FFR assessment with dipyridamole, infused in a peripheral vein, as pharmacological agent inducing maximal hyperaemia , compared to a continuous adenosine infusion in a central vein, considered as the “gold standard”. The diagnostic accuracy will be measured with ROC curves analysis.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate a better tolerability and a reduction of side effects with dipyridamole, compared to adenosine infusion, with a tolerability test for each drug.;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public ContactU.O. EMODINAMICA

FONDAZIONE TOSCANA GABRIELE MONASTERIO

marco.vaghetti@ftgm.it0585-493507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026