Persantin Preceding PCI - P3

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004620-20-NL

Enrollment

250

Registered

2007-08-30

Start date

2008-05-21

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

myocardial damage due to PCI MedDRA version: 9.1 Level: LLT Classification code 10065554 Term: Myocardial infarction prophylaxis

Interventions

Trade Name: Persantin Pharmaceutical Form: Capsule* CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Cap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Patients accepted for elective single, native vessel (left anterior descending, right coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC or RUNMC cardiology policlinic patients undergoing diagnostic coronary angiography. · Troponin-I =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · unstable angina · recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion · 3-Vessel disease as seen on coronary angiogram · Stenotic laesion in mainstem as seen on coronary angiogram · CABG in medical history · asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists) · Diabetes Mellitus type I (insuline dependent) · Use of prescribtioned oral anticoagulants (coumarine derivates) · Use of oral corticosteroids · Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride) · Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID’s)

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of pretreatment with Persantin (retard, 2dd200mg, at least 3 days) in patients undergoing PCI on periprocedural troponin-I release. ;Secondary Objective: To study the effect of pretreatment with dipyridamole (Persantin Retard, 2dd200mg) in patients undergoing PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6) and insulin resistance (plasma glucose, insulin and adiponectin) before and after pretreatment with dipyridamole and before and after PCI. ;Primary end point(s): Elevated Troponin-I (=0.20 ug/L) 8 hours after PCI	—

Measure

Time frame

Main Objective: To study the effect of pretreatment with Persantin (retard, 2dd200mg, at least 3 days) in patients undergoing PCI on periprocedural troponin-I release. ;Secondary Objective: To study the effect of pretreatment with dipyridamole (Persantin Retard, 2dd200mg) in patients undergoing PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6) and insulin resistance (plasma glucose, insulin and adiponectin) before and after pretreatment with dipyridamole and before and after PCI. ;Primary end point(s): Elevated Troponin-I (=0.20 ug/L) 8 hours after PCI

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Countries

Netherlands

Outcome results

None listed

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