ELISA-2 (Early or Late Intervention in unStable Angina).

Angiography and Revascularisation after 24 hours pre-treatment with Tirofiban compared to Angiography after Pre-Treatment with Clopidogrel in High Risk Patients with Unstable Angina.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24053

Enrollment

330

Registered

2005-08-02

Start date

2002-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute coronary syndrome.

Interventions

Angiography and Revascularisation (PCI) after 24 hours pre-treatment with Tirofiban compared to Angiography after Pre-Treatment with Clopidogrel in High Risk Patients with Unstable Angina.

Eligibility

Inclusion criteria

Inclusion criteria: (at least 2 out of 3 of the following): 1. Ischemic Chest Pain at rest with last attack 0,1 mVolt in 2 leads; 3. Evidence of myocardial damage: Positive Troponin (>0.05 microgr/l) or Myoglobin (>200 microg/l) on admission or 3 hours later or; 4. Positive CPKmb fraction on admission.

Exclusion criteria

Exclusion criteria: 1. Age 80 years; 2. Persistent ST segment elevation; 3. Cardiogenic Shock or pulmonary edema; 4. Myocardial ischemia precipitated by non-cardiac condition (anemia, hyperthyroidism); 5. PTCA within previous 6 months; 6. Renal failure/Liver failure.

Design outcomes

Primary

Measure	Time frame
The Tirofiban strategy results in a smaller enzymatic infarct size, compared to the Clopidogrel strategy.	—

Secondary

Measure	Time frame
1. Enzymatic Infarct Size (LDHQ72); 2. Hospital Stay. Total duration in hospital in days, including admission and discharge day. Do Dexamethason-coated Stents Decrease the incidence of Restenosis in patients with an Acute Coronary Syndrome? 3.Clinical endpoints 3.1 Death Total mortality will be assessed at 30 days follow-up. 3.2 Myocardial Infarction a. Early MI in patients presenting with CKmb > upper limit of normal. b. Early MI in patients presenting with CKmb not exceeding the upper limit of normal c. Late MI in patients whose CKmb has returmed to (or has remained) normal. d. MI in patients who underwent CABG. 3.3 Stroke All (hemorrhagic and non-hemorrhagic) strokes must be confirmed by CT scan examination and after consultation of a neurologist. 3.4 Bleeding 2.Secondary Efficacy Parameter The Tirofiban strategy results in a better patency of the culprit coronary artery before intervention. 2.1Coronary Angiography All angiography films will be evaluated by an independent core-laboratory (DIAGRAM, Zwolle, the Netherlands), without access to clinical data.	—

Measure

Time frame

1. Enzymatic Infarct Size (LDHQ72); 2. Hospital Stay. Total duration in hospital in days, including admission and discharge day. Do Dexamethason-coated Stents Decrease the incidence of Restenosis in patients with an Acute Coronary Syndrome? 3.Clinical endpoints 3.1 Death Total mortality will be assessed at 30 days follow-up. 3.2 Myocardial Infarction a. Early MI in patients presenting with CKmb > upper limit of normal. b. Early MI in patients presenting with CKmb not exceeding the upper limit of normal c. Late MI in patients whose CKmb has returmed to (or has remained) normal. d. MI in patients who underwent CABG. 3.3 Stroke All (hemorrhagic and non-hemorrhagic) strokes must be confirmed by CT scan examination and after consultation of a neurologist. 3.4 Bleeding 2.Secondary Efficacy Parameter The Tirofiban strategy results in a better patency of the culprit coronary artery before intervention. 2.1Coronary Angiography All angiography films will be evaluated by an independent core-laboratory (DIAGRAM, Zwolle, the Netherlands), without access to clinical data.

—

Contacts

Public ContactJ. Klijn

Diagram B.V. Zwolle Dokter Stolteweg 96

j.klijn@diagram-zwolle.nl+31 (0)38 4262997

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)