A Comparison of Drug Eluting and Bare Metal Stents with Bivalirudin during PCI or Bivalirudin for 4 hours in Acute Coronary Syndromes. The Eindhoven Reperfusion Study - The DEBATER 2 Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023779-24-NL

Enrollment

1800

Registered

2010-11-11

Start date

2010-12-06

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel

Interventions

Trade Name: Angiox Product Name: Angiox Pharmaceutical Form: Powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: STEMI 5 mm in right precordial leads V1-V3 (discordant with QRS) ST-segment depression/T wave inversion V1-V3 ST-segment elevation = 1 mm concordant with a large R wave Criteria for high-risk NSTEMI Patients with recurrent ischemia/chest pain Dynamic ECG changes (ST-segment depression or transient ST-segment elevation) Elevated troponin levels Early post infarction unstable angina Diabetes Hemodynamic instability Major arrhythmias (VF, VT) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindication for PCI: peripheral/coronary artery disease that is inaccessible for PCI Contraindication for GPI: ongoing bleeding, bleeding diathesis, cerebrovascular accident in the last 6 months, major surgery/trauma in the last 6 months, platelet count < 100.000 mm3, intracranial intravenous malformation or neoplasm, malignant hypertension, INR . 1.5, severe hepatic dysfunction Contraindication for bivalirudin: bleeding diathesis, thrombocytopathy, thrombocytopenia, coagulopathy, recent surgery, TIA or CVA, severe uncontrolled hypertension, active peptic ulcer, severe renal insufficiency (MDRD < 30 ml/min). Contraindication for clopidogrel: severe hepatic dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding Thrombolytic therapy within the last 24 hours Therapy with GPI within the last 24 hours Anticoagulation therapy C-morbid conditions with a predictable fatal outcome in the short run No informed consent: refusal, (sub) coma, artificial respiration, impaired mentation Patients who are already included in DEBATER II or in other trials

Design outcomes

Primary

Measure	Time frame
Main Objective: The DEBATER 2 study is a single centre, investigator-initiated, prospective open 2x2 factorial randomized trial with independent data management, independent statistical analysis and blinded endpoint evaluation. The study is designed to determine the non-inferiority of TITANOX over EES and to determine the superiority of bivalirudin during 4 hours over bivalirudin during PCI in patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel, and post-treated with DD clopidogrel for 1 week after PCI. ;Secondary Objective: The composite of all-cause mortality, any myocardial infarction, bleeding and stroke at 30 days;Primary end point(s): Primary Endpoints (for the comparison of stents): The device-oriented primary endpoint is the composite of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 1 year. The patient-oriented primary endpoint is the composite of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels). Primary Endpoints (for Bivalirudin): The device-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 30 days. The patient-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels) at 30 days.	—

Measure

Time frame

Main Objective: The DEBATER 2 study is a single centre, investigator-initiated, prospective open 2x2 factorial randomized trial with independent data management, independent statistical analysis and blinded endpoint evaluation. The study is designed to determine the non-inferiority of TITANOX over EES and to determine the superiority of bivalirudin during 4 hours over bivalirudin during PCI in patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel, and post-treated with DD clopidogrel for 1 week after PCI. ;Secondary Objective: The composite of all-cause mortality, any myocardial infarction, bleeding and stroke at 30 days;Primary end point(s): Primary Endpoints (for the comparison of stents): The device-oriented primary endpoint is the composite of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 1 year. The patient-oriented primary endpoint is the composite of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels). Primary Endpoints (for Bivalirudin): The device-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 30 days. The patient-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels) at 30 days.

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Countries

Netherlands

Outcome results

None listed

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